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Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

Trial Profile

Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2024

At a glance

  • Drugs Cilgavimab/tixagevimab (Primary) ; Hydroxychloroquine (Primary) ; Interferon beta-1a (Primary) ; Interferon beta-1a (Primary) ; Lopinavir/ritonavir (Primary) ; Lopinavir/ritonavir (Primary) ; Remdesivir (Primary)
  • Indications COVID-19 respiratory infection
  • Focus Therapeutic Use
  • Acronyms DisCoVeRy
  • Most Recent Events

    • 05 Apr 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
    • 24 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 12 Sep 2023 This trial has been discontinued in Ireland, according to the European Clinical Trials Database record.

Trial Overview

Purpose

DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19.

Primary Endpoints

Percentage of subjects reporting each severity rating on a 7-point ordinal scale

description: Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or ECMO;
Death.
time_frame: Day 15

Other Endpoints

Status on an ordinal scale

description: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale
time_frame: Days 29, 90, 180 and 365

National Early Warning Score 2 (NEWS-2 score)

description: Change from baseline in NEWS-2.
time_frame: Days 3, 8, 15, and 29

Number of oxygenation free days in the first 28 days

time_frame: 29 days

Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.

time_frame: 29 days

Ventilator free days in the first 28 days

time_frame: 29 days

Incidence of new mechanical ventilation use during the trial.

time_frame: 29 days

Need for mechanical ventilation or death by Day 15

description: Proportion of patients with mechanical ventilation or death at day 15
time_frame: Day 15

Hospitalization

description: Time to hospital discharge (days).
time_frame: 29 days

Mortality

description: Rate of mortality
time_frame: In hospital, Days 29, 90, 180, 365, 456

Occurrence of new hospitalization

time_frame: Days 90, 180 and 365

Occurrence of confirmed re-infection with SARS-CoV-2

time_frame: Days 90, 180 and 365

Cumulative incidence of serious adverse events (SAEs)

time_frame: 29 days

Cumulative incidence of Grade 1- 2 hypersensitivity- related and infusion related AEs until D29 visit

time_frame: 29 days

Cumulative incidence of Grade 3 and 4 adverse events (AEs)

time_frame: 29 days

Number of participants with a discontinuation or temporary suspension of study drugs (for any reason)

time_frame: 29 days

Cumulative incidence of AEs of Special Interest

time_frame: 29 days

Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample

time_frame: Days 3, 5, 8, 11, 15, 29

Quantitative SARS-CoV-2 virus in nasopharyngeal sample

time_frame: Days 3, 5, 8, 11, 15, 29

Quantitative SARS-CoV-2 virus in blood

time_frame: Days 3, 8 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 respiratory infection treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 3100

    Actual: 1552

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

1. Adult ≥18 years of age at the time of enrolment 2. Hospitalized patients with any of the following criteria: 1. the presence of pulmonary rales/crackles on clinical exam OR 2. SpO2 ≤ 94% on room air OR 3. requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation 3. A time between onset of symptoms and randomization of less than 11 days 4. A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days preceding randomization 5. The result of a rapid antigen test performed on a NP swab within the 6 hours preceding randomization 6. Contraceptive use by men or women. 1. Male participants: Contraception for male participants is required; to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue for 90 days following administration of IMP. 2. Female participants: Women of child-bearing potential must agree to use contraception for 365 days following administration of IMP.

Patient Exclusion Criteria

1. Refusal to participate expressed by patient or legally authorized representative 2. Need for invasive mechanical ventilation and/or ECMO at the time of enrolment 3. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal 4. Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance dialysis 5. Pregnancy or breast-feeding 6. Anticipated transfer to another hospital, which is not a study site within 72 hours following randomization 7. Known history of allergy or reaction to any component of the study drug formulation. 8. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies. 9. Any prior receipt of investigational or licensed other mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19, and for those not vaccinated, expected receipt of vaccine in the 30 days following hospital discharge, according to current recommendation in each country. 10. Any medical condition which, in the judgment of the investigator, could interfere with the interpretation of the trial results or that preludes to protocol adherence.

Trial Details

Identifiers

Identifier Owner
NCT04315948 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-000936-23 European Clinical Trials Database
C20-15 -
101015736 -

Organisations

  • Affiliations AbbVie; AstraZeneca; Cipla; Faron Pharmaceuticals; Gilead Sciences; Merck & Co; Mylan

Trial Dates

  • Initiation Dates

    Planned : 01 Mar 2020

    Actual : 22 Mar 2020

  • Primary Completion Dates

    Planned : 01 Jul 2022

    Actual : 09 Jul 2022

  • End Dates

    Planned : 01 Oct 2023

    Actual : 25 Sep 2023

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Austria; Belgium; Czech Republic; France; Greece; Hungary; Ireland; Luxembourg; Norway; Poland; Portugal; Slovakia; Spain; Turkey
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Cilgavimab/tixagevimabPrimary Drug Intravenous Infusion, Injection
HydroxychloroquinePrimary Drug Oral Tablet
Interferon beta-1aPrimary Drug Intravenous
-
Interferon beta-1aPrimary Drug Subcutaneous Injection
Lopinavir/ritonavirPrimary Drug Nasogastric Solution, Suspension
Lopinavir/ritonavirPrimary Drug Oral Tablet
RemdesivirPrimary Drug Intravenous Infusion, Lyophilised

Remdesivir

Remdesivir will be administered as a 200 mg intravenous loading dose on Day 1, followed by a 100 mg once-daily intravenous maintenance dose for the duration of the hospitalization up to a 10 days total course.
n=475
Drug: Remdesivir (The lyophilized formulation of Remdesivir is a preservative-free, white to off-white or yellow, lyophilized solid containing 100 mg of Remdesivir to be reconstituted with 19 mL of sterile water for injection and diluted into IV infusion fluids prior to IV infusion. Following reconstitution, each vial contains a 5 mg/mL Remdesivir concentrated solution with sufficient volume to allow withdrawal of 20 mL (100 mg of remdesivir). It is supplied as a sterile product in a single-use, 30 mL, Type 1 clear glass vial.)
Other: Standard of care (Standard of care)

Lopinavir/ritonavir (stopped on June 29, 2020)

Lopinavir/ritonavir (400 lopinavir mg/100 mg ritonavir) will be administered every 12 h for 14 days in tablet form. For patients who are unable to take medications by mouth, the lopinavir/ritonavir (400 lopinavir mg/100 mg ritonavir) will be administered as a 5-ml suspension every 12 h for 14 days via a pre-existing or newly placed nasogastric tube.
n=620
Drug: Lopinavir/ritonavir (The oral tablets of lopinavir/ritonavir contain 200 mg lopinavir, 50 mg ritonavir. They have a yellow colour, film-coated, ovaloid shape debossed with the "a" logo and the code KA. The oral solution for patients who cannot swallow is a light yellow to orange colored liquid containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL).)
Other: Standard of care (Standard of care)

Lopinavir/ritonavir plus Interferon ß-1a (stopped on June 29)

Lopinavir/ritonavir (400 lopinavir mg/100 mg ritonavir) will be administered every 12 h for 14 days in tablet form. For patients who are unable to take medications by mouth, the lopinavir/ritonavir (400 lopinavir mg/100 mg ritonavir) will be administered as a 5-ml suspension every 12 h for 14 days via a pre-existing or newly placed nasogastric tube.
Interferon ß1a will be administered subcutaneously at the dose of 44 µg for a total of 3 doses in 6 days (day 1, day 3, day 6).
n=620
Drug: Lopinavir/ritonavir (The oral tablets of lopinavir/ritonavir contain 200 mg lopinavir, 50 mg ritonavir. They have a yellow colour, film-coated, ovaloid shape debossed with the "a" logo and the code KA. The oral solution for patients who cannot swallow is a light yellow to orange colored liquid containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL).)
Drug: Interferon Beta-1A (IFN-ß-1a is supplied as a sterile solution containing no preservative available in a prefilled syringe. It will be provided as a single-dose prefilled graduated syringe with 44 µg per 0.5 mL. The liquid should be clear to slightly yellow. Do not use if the liquid is cloudy, discolored or contains particles. Use a different syringe.)
Other: Standard of care (Standard of care)

Hydroxychloroquine (stopped on May 24, 2020)

Hydroxychloroquine will be administered orally as a loading dose of 400 mg twice daily for one day followed by 400 mg once daily for 9 days. The loading dose of hydroxychloroquine through a nasogastric tube will be increased to 600 mg twice a day for one day, followed by a maintenance dose of 400 mg once a day for 9 days n=620
Drug: Hydroxychloroquine (Hydroxychloroquine is supplied as film-coated 200 mg tablets. Hydroxychloroquine sulfate tablets are presented as white or whitish, peanut-shaped, oblong or round film-coated tablets containing 200 mg of hydroxychloroquine sulfate (equivalent to 155 mg base).)
Other: Standard of care (Standard of care)

AZD7442

Participants randomized to the AZD7442 group will receive a total dose of 600 mg AZD7442 via a co-administered (300 mg AZD8895 and 300 mg AZD1061) single IV infusion on Day 1.
n=620
Other: Standard of care (Standard of care)
Drug: AZD7442 (AZD7442 will be supplied as separate vials of AZD8895 and AZD1061 containing 150 mg colorless to slightly yellow, clear to opalescent solutions for injection.)

Standard of care alone

Standard of care alone before March, 2021.
Other: Standard of care (Standard of care)

Standard of care with placebo

Standard of care with placebo since April, 2021 n=620
Other: Standard of care (Standard of care)
Other: Placebo (Since April, 2021, the placebo will be a 0.9% (w/v) NaCl solution for infusion also called saline. The placebo will be supplied as a single 10-mL, clear and colorless vial.)

Results

Publications

  1. Lingas G, Neant N, Gaymard A, Belhadi D, Peytavin G, Hites M, et al. Effect of remdesivir on viral dynamics in COVID-19 hospitalized patients: a modelling analysis of the randomized, controlled, open-label DisCoVeRy trial. . J-Antimicrob-Chemother 2022;.

    PubMed | CrossRef Fulltext
  2. Lingas G, Neant N, Gaymard A, Belhadi D, Hites M, Costagliola D, et al. Modeling Remdesivir Antiviral Efficacy in Covid-19 Hospitalized Patients. CROI-2022 2022; abstr. 455.

    Available from: URL: http://www.croiconference.org/
  3. Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Poissy J, Belhadi D, et al. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet-Infect-Dis 2022;22(2):209-221.

    PubMed | CrossRef Fulltext
  4. Zhang R, Mylonakis E. In inpatients with COVID-19, none of remdesivir, hydroxychloroquine, lopinavir, or interferon beta-1a differed from standard care for in-hospital mortality. . Ann-Intern-Med 2021;.

    PubMed | CrossRef Fulltext
  5. Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, et al. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Abdool Karim Q 1 - -
Abi Hanna P 1 - -
Ader F 4 1 -
Al-Bader AM 1 - -
Alejandria MM 1 - -
Alhasawi A 1 - -
Allum E 1 - -
Alotaibi A 1 - -
Alvarez-Moreno CA 1 - -
Appadoo S 1 - -
Asiri A 1 - -
Aukrust P 1 - -
Barratt-Due A 1 - -
Belhadi D 3 - -
Bellani S 1 - -
Bouscambert-Duchamp M 3 - 2
Branca M 1 - -
Burdet C 3 - -
Cappel-Porter HBC 1 - -
Cerrato N 1 - -
Chow TS 1 - -
Como N 1 - -
Costagliola D 3 - -
Diallo A 1 - -
DisCoVeRy Study Group 1 - 1
Eustace J 1 - -
Gagneux-Brunon A 2 - -
Garcia PJ 1 - -
Gaymard A 2 - -
Godbole S 1 - -
Gotuzzo E 1 - -
Greil R 2 - -
Griskevicius L 1 - -
Guedj J 3 - -
Hamra R 1 - -
Hassan M 1 - -
Hassany M 1 - -
Henao-Restrepo AM 1 - -
Hernandez Garcia C 1 - -
Hites M 3 - -
Hutton D 1 - -
Irmansyah I 1 - -
Jancoriene L 1 - -
Kieny MP 1 - -
Kirwan J 1 - -
Kumar S 1 - -
Le MP 1 - -
Lennon P 1 - -
Lingas G 2 2 -
Lopardo G 1 - -
Lydon P 1 - -
Magrini N 1 - -
Maguire T 1 - -
Malekzadeh R 1 - -
Manevska S 1 - -
Manuel O 1 - -
McGinty S 1 - -
Medina MT 1 - -
Mentre F 3 - -
Mesa Rubio ML 1 - -
Miranda-Montoya MC 1 - -
Murthy S 1 - -
Mylonakis E 1 - 1
Neant N 2 - -
Nel J 1 - -
Nunes EP 1 - -
Paiva JA 2 - -
Pan H 1 1 -
Peiffer-Smadja N 2 - -
Perola M 1 - -
Peto R 1 - -
Peytavin G 2 - -
Poissy J 2 - -
Portoles A 1 - -
Preziosi MP 1 - -
Rasmin MR 1 - -
Raza A 1 - -
Reddy KS 1 - -
Rees H 1 - -
Reges PPS 1 - -
Rogers CA 1 - -
Roses Periago M 1 - -
Rottingen JA 1 - -
Salami K 1 - -
Salvadori MI 1 - -
Sathiyamoorthy V 1 - -
Sinani N 1 - -
Staub T 2 - -
Sterne JAC 1 - -
Stevanovikj M 1 - -
Swaminathan S 1 - 1
Tacconelli E 1 - -
Tikkinen KAO 1 - -
Trelle S 1 - -
Wallet F 2 - -
Yazdanpanah Y 3 - -
Zaid H 1 - -
Zhang R 1 1 -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Adrien LEMAIGNEN Centre Hospitalier Universitaire de Tours France
Agathe DELBOVE CH Bretagne Atlantique France
Anastasia Kotanidou Evaggelismos General Hospital Greece
André CABIE Centre Hospitalier Universitaire de Martinique France
Anna Piekarska Bienganski Hospital Poland
Anne Ma Dyrhol Riise Oslo University Hospital Norway
Armand MEKONTSO DESSAP APHP - hôpital Henri-Mondor France
Bertrand SOUWEINE CHU Clermont-Ferrand France
Brian KENT hospital Saint James Ireland
Bruno MOURVILLIER CHU de Reims France
Béatrice RIU-POULENC Centre Hospitalier Universitaire de Toulouse France
Carolina Akinosoglou General University Hospital of Patras Greece
Christelle DELMAS
8 rue de la Croix Jarry
Paris
Postcode: 75013
France
Telephone: 33182 53 33 68
christelle.delmas@inserm.fr
show details
INSERM France
Claire ROGER CHU Nîmes France
Clotilde Visée Pôle Hospitalier Jolimont / site de Mons-Warquignies Belgium
Cyrille CHABARTIER Centre Hospitalier Universitaire de Martinique France
David BOUGON Centre Hospitalier Annecy Genevois France
Denis GAROT Centre Hospitalier Universitaire de Tours France
Denis MALVY Centre Hospitalier Universitaire de Bordeaux France
Didier GRUSON Centre Hospitalier Universitaire de Bordeaux France
Dušan Krkoška Martin University Hospital Slovakia
Elisabeth BOTELHO-NEVERS Centre Hospitalier Universitaire de Saint Etienne France
Elisabeth ROUVEIX-NORDON CHU APHP Ambroise-Paré France
Emma D'ANGLEJAN Centre hospitalier de Versailles France
Emmanuel Faure Centre Hospitalier Régional Universitaire de Lille France
Fanny BOUNES - VARDON Centre Hospitalier Universitaire de Toulouse France
Fanny LANTERNIER APHP - Hôpital Necker France
Ferhat MEZIANI Centre Hospitalier Régional Universitaire de Strasbourg France
Firouze BANI-SADR CHU de Reims France
Flore LACASSIN-BELLER Centre Hospitalier de Mont de Marsan France
Florence ADER Hospices Civils de Lyon France
Florence Ader, MD
+33 (0)4 72 07 15 60 florence.ader@chu-lyon.fr
show details
Hospices Civils de Lyon France
France CAZENAVE-ROBLOT CHU Poitiers France
François BENEZIT Centre Hospitalier Universitaire de Rennes France
François DANION Centre Hospitalier Régional Universitaire de Strasbourg France
François GOEHRINGER Centre Hospitalier Régional et Universitaire de Nancy France
François Raffi Centre Hospitalier Universitaire de Nantes France
Gilles PIALOUX APHP - Hôpital Tenon France
Guilhem WATTECAMPS CH Cornouaille France
Guillaume GERI CHU APHP Ambroise-Paré France
Guillaume MARTIN BLONDEL Centre Hospitalier Universitaire de Toulouse France
Guillaume THIERY Centre Hospitalier Universitaire de Saint Etienne France
Hafid AIT TOUFELLA APHP - Hôpital Saint Antoine France
Henry LESSIRE Hospices Civil France
Hélène Espérou, MD
+33 1 44 23 60 70 helene.esperou@inserm.fr
show details
INSERM France
Jean DELLAMONICA Centre Hospitalo-Universitaire de Nice France
Jean Reignier Centre Hospitalier Universitaire de Nantes France
Jean-Christophe NAVELLOU Centre Hospitalier Régional Universitaire de Besançon France
Jean-Christophe RICHARD Hospices Civils de Lyon France
Jean-François Timsit APHP - Hôpital Bichat Claude Bernard France
Jean-Philippe LANOIX Centre Hospitalier Universitaire Amiens-Picardie France
Jean-Pierre QUENOT Centre Hospitalier Universitaire Dijon-Bourgogne France
Johan COURJEON Centre Hospitalo-Universitaire de Nice France
Joy MOOTIEN Groupe Hospitalier de la Région de Mulhouse Sud Alsace France
Julien Poissy Centre Hospitalier Régional Universitaire de Lille France
Kada KLOUCHE Centre Hospitalier Universitaire de Montpellier France
Karine LACOMBE APHP - Hôpital Saint Antoine France
Kevin BOUILLER Centre Hospitalier Régional Universitaire de Besançon France
Leila BELKHIR Hôpital Saint Luc Belgium
Lionel PIROTH Centre Hospitalier Universitaire Dijon-Bourgogne France
Marie GOUSSEFF CH Bretagne Atlantique France
Martin MARTINOT Hospices Civil France
Maya HITES Hôpital Erasme - Cliniques universitaires de Bruxelles Belgium
Michal Rezek Fakultní nemocnice u sv. Anny v Brně Czech-Republic
Nadia SAIDANI CH Cornouaille France
Nathalie DE CASTRO APHP - Hôpital Saint Louis France
Nathan Peiffer-Smadja APHP - Hôpital Bichat Claude Bernard France
Olav Dalgard Akershus Unniversity Hospital Norway
Olivier HINSCHBERGER Groupe Hospitalier de la Région de Mulhouse Sud Alsace France
Olivier LESENS CHU Clermont-Ferrand France
Philippe Clevenbergh CHU Brugmann Belgium
Pierre SELLIER APHP - Hôpital Lariboisière France
Richard GREIL Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität Austria
Samy FIGUEIREDO AP-HP Hôpital Bicêtre France
Simen Schive Lovisenberg Diaconal Hospital Norway
Stéphane JAUREGUIBERRY AP-HP Hôpital Bicêtre France
Sébastien GALLIEN APHP - hôpital Henri-Mondor France
Sébastien GIBOT Centre Hospitalier Régional et Universitaire de Nancy France
Thérèse STAUB Centre Hospitalier Luxembourg Luxembourg
Vincent LE MOING Centre Hospitalier Universitaire de Montpellier France
Violaine TOLSMA Centre Hospitalier Annecy Genevois France
Yacine TANDJAOUI-LAMBIOTTE Hopital DELAFONTAINE France
Yoann ZERBIB Centre Hospitalier Universitaire Amiens-Picardie France
Yves LE TULZO Centre Hospitalier Universitaire de Rennes France

Centres

Centre Name Location Trial Centre Country
Akershus Unniversity Hospital Oslo Norway
AP-HP Hôpital Bicêtre Kremlin-Bicêtre France
APHP - Hôpital Bichat Claude Bernard Paris France
APHP - Hôpital Cochin Paris France
APHP - hôpital Henri-Mondor Créteil France
APHP - Hôpital Lariboisière Paris France
APHP - Hôpital Necker Paris France
APHP - Hôpital Saint Antoine Paris France
APHP - Hôpital Saint Louis Paris France
APHP - Hôpital Tenon Paris France
APHP - Hôpital Universitaire Pitié Salpêtrière Paris France
APHP- Hôpital Européen Georges-Pompidou Paris France
Bienganski Hospital Łódź Poland
Centre Hospitalier Andrée Rosemon Cayenne France
Centre Hospitalier Annecy Genevois Épagny France
Centre Hospitalier de Mont de Marsan Mont-de-Marsan France
Centre Hospitalier de Tourcoing Tourcoing France
Centre hospitalier de Versailles Le Chesnay France
Centre Hospitalier Luxembourg Luxembourg Luxembourg
Centre Hospitalier Regional Metz-Thionville Ars-Laquenexy France
Centre Hospitalier Régional et Universitaire de Nancy Nancy France
Centre Hospitalier Régional Universitaire de Besançon Besançon France
Centre Hospitalier Régional Universitaire de Lille Lille France
Centre Hospitalier Régional Universitaire de Strasbourg Strasbourg France
Centre Hospitalier Universitaire Amiens-Picardie Amiens France
Centre Hospitalier Universitaire de Bordeaux Bordeaux France
Centre Hospitalier Universitaire de Martinique Fort De France France
Centre Hospitalier Universitaire de Montpellier Montpellier France
Centre Hospitalier Universitaire de Nantes Nantes France
Centre Hospitalier Universitaire de Rennes Rennes France
Centre Hospitalier Universitaire de Saint Etienne Saint-Étienne France
Centre Hospitalier Universitaire de Toulouse Toulouse France
Centre Hospitalier Universitaire de Tours Tours France
Centre Hospitalier Universitaire Dijon-Bourgogne Dijon France
Centre Hospitalo-Universitaire de Grenoble La Tronche France
Centre Hospitalo-Universitaire de Nice Nice France
Centro Hospitalar Universitário de São João, EPE Porto Portugal
CH Bretagne Atlantique Vannes France
CH Cornouaille Quimper France
CHU APHP Ambroise-Paré Boulogne-Billancourt France
CHU Brugmann Brussels Belgium
CHU Clermont-Ferrand Clermont-Ferrand France
CHU de Reims Reims France
CHU Nîmes Nîmes France
CHU Poitiers Poitiers France
CHULN- Hospital de Santa Maria Lisboa Portugal
Evaggelismos General Hospital Athens Greece
Fakultní nemocnice u sv. Anny v Brně Brno Czech-Republic
General University Hospital of Patras Patras Greece
Groupe Hospitalier de la Région de Mulhouse Sud Alsace Mulhouse France
Hopital DELAFONTAINE Saint-Denis France
Hospices Civil Colmar France
Hospices Civils de Lyon Lyon France
Hospital de Abrantes (CHMT) Abrantes Portugal
Hospital de Cascais Cascais Portugal
hospital Saint James Dublin Ireland
Hôpital d'Instruction des Armées BEGIN Saint-Mandé France
Hôpital Erasme - Cliniques universitaires de Bruxelles Brussels Belgium
Hôpital La Citadelle Liège Belgium
Hôpital Paris Saint-Joseph et Marie Lannelongue Paris France
Hôpital Saint Luc Brussels Belgium
Hôpitaux Robert Schuman Luxembourg Luxembourg
INSERM
-
-
INSERM Paris, France
Institut National de la Santé Et de la Recherche Médicale, France
-
-
Kepler Universitätsklinikum Linz Linz Austria
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität Salzburg Austria
Lovisenberg Diaconal Hospital Oslo Norway
Martin University Hospital Martin Slovakia
Medizinische Universität Innsbruck Innsbruck Austria
Oslo University Hospital Oslo Norway
Pôle Hospitalier Jolimont / site de Mons-Warquignies Mons Belgium

Trial History

Event Date Event Type Comment
08 Apr 2024 Other trial event Last checked against European Clinical Trials Database record. Updated 08 Apr 2024
05 Apr 2024 Other trial event This trial has been completed in Portugal, according to European Clinical Trials Database record. Updated 08 Apr 2024
30 Nov 2023 Other trial event Last checked against ClinicalTrials.gov record. Updated 30 Nov 2023
24 Nov 2023 Status change - completed Status changed from active, no longer recruiting to completed. Updated 30 Nov 2023
12 Sep 2023 Other trial event This trial has been discontinued in Ireland, according to the European Clinical Trials Database record. Updated 13 Sep 2023
05 Jul 2023 Other trial event This trial has been discontinued in Norway (End Date: 10 Jan 2023), according to European Clinical Trials Database record. Updated 05 Jul 2023
31 Jul 2022 Other trial event This trial has been completed in Slovakia, according to European Clinical Trials Database record. Updated 02 Aug 2022
14 Jul 2022 Other trial event This trial has been completed in Austria, Czechia and Hungary, according to European Clinical Trials Database record. Updated 18 Jul 2022
01 Jul 2022 Completion date Planned End Date changed from 1 Mar 2023 to 1 Oct 2023. Updated 07 Jul 2022
01 Jul 2022 Other trial event Planned primary completion date changed from 1 Mar 2023 to 1 Jul 2022. Updated 07 Jul 2022
01 Jul 2022 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 07 Jul 2022
10 Mar 2022 Other trial event This trial has been suspended in Austria, according to European Clinical Trials Database record. Updated 10 Mar 2022
02 Mar 2022 Results Results (n=665) assessing the effect of remdesivir in blocking viral replication published in the Journal of Antimicrobial Chemotherapy Updated 08 Mar 2022
16 Feb 2022 Results Results of an analysis assessed the nasopharyngeal normalized viral loads presented at the 29th Conference on Retroviruses and Opportunistic Infections Updated 01 Apr 2022
01 Feb 2022 Results Results (n=857) published in The Lancet Infectious Diseases Updated 22 Feb 2022
31 Aug 2021 Status change - recruiting Status changed from active, no longer recruiting to recruiting. Updated 03 Sep 2021
22 Apr 2021 Protocol amendment Protocol amended to add AZD-7442 double blinded arm to trial planned number of patient changed. Updated 29 Apr 2021
22 Apr 2021 Other trial event Planned number of patients changed from 3100 to 2416. Updated 29 Apr 2021
11 Feb 2021 Other trial event This trial has been suspended in Austria, according to European Clinical Trials Database record. Updated 11 Feb 2021
02 Feb 2021 Interim results Results published in the Annals of Internal Medicine Updated 05 Feb 2021
01 Feb 2021 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 04 Feb 2021
02 Dec 2020 Interim results Interim results (n=11330) published in the New England Journal of Medicine Updated 28 Dec 2020
19 Nov 2020 Other trial event Trial design of SOLIDARITY and DISCOVERY, presented at the 23rd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research. Updated 20 Nov 2020
30 Apr 2020 Other trial event According to a Faron Pharmaceuticals media release, over 90 countries involved in this trial. Updated 04 May 2020
24 Mar 2020 Other trial event New source identified and integrated,European Clinical Trials Database;EudraCT2020-000936-23. Updated 24 Mar 2020
23 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 27 Mar 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

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  2. Lingas G, Neant N, Gaymard A, Belhadi D, Peytavin G, Hites M, et al. Effect of remdesivir on viral dynamics in COVID-19 hospitalized patients: a modelling analysis of the randomized, controlled, open-label DisCoVeRy trial. . J-Antimicrob-Chemother 2022;.

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  3. European Clinical Trials Database. Trial-Reg 2023;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  4. Lingas G, Neant N, Gaymard A, Belhadi D, Hites M, Costagliola D, et al. Modeling Remdesivir Antiviral Efficacy in Covid-19 Hospitalized Patients. CROI-2022 2022; abstr. 455.

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  5. Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Poissy J, Belhadi D, et al. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet-Infect-Dis 2022;22(2):209-221.

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  9. Liang S, Qiu T, Wang Y, Han R, Dabbous O, Toumi M. COVID-19- Why Solidarity and Discovery Trials MAY Fail to Bring Informative and Timely Results? EISPOR-2020 2020; abstr. PDG75.

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