Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults
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
- 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.
Most Recent Events
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 |
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|
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
-
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 -
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/ -
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 -
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 -
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
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
show details
Paris Postcode: 75013 France Telephone: 33182 53 33 68 christelle.delmas@inserm.fr |
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 |
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INSERM | Paris, | France |
Institut National de la Santé Et de la Recherche Médicale, France |
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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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
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 -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
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/ -
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 -
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