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Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Trial Profile

Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Jul 2020

At a glance

  • Drugs Baricitinib (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections; Respiratory tract infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 22 Jul 2020 Number of arms changed from 3 to 2. Drug Lopinavir/ritonavir and experimental arm: Lopinavir/ritonavir removed from study protocol. Planned number of subjects also decreased.
    • 22 Jul 2020 Planned number of patients changed from 1000 to 800.
    • 02 Jul 2020 Number of arms changed from 4 to 3. Drug Hydroxychloroquine sulfate and experimental arm: Hydroxychloroquine sulfate removed from study protocol.

Trial Overview

Purpose

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.

Primary Endpoints

Clinical status of subject at day 15 (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: Up to 15 days

Other Endpoints

Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.

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: Up to 180 days

Length of time to clinical improvement

description: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.
time_frame: Up to 29 days

Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29

time_frame: Up to 29 days

Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment

time_frame: Up to 24 weeks

Length of time to clinical progression

description: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission
time_frame: Up to 29 days

Cause of death (if applicable)

time_frame: Up to 24 weeks

Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)

time_frame: Up to 29 days

Length of time to normalization of fever

description: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours
time_frame: Up to 29 days

Length of time to normalization of oxygen saturation

description: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.
time_frame: Up to 29 days

Duration of supplemental oxygen (if applicable)

time_frame: Up to 29 days

Duration of mechanical ventilation (if applicable)

time_frame: Up to 29 days

Duration of hospitalization

time_frame: Up to 29 days

Adverse events

time_frame: Up to 180 days

Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm

time_frame: Up to 180 days

Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180.

time_frame: Up to 180 days

Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180.

time_frame: Up to 180 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Adult respiratory distress syndrome treatment -
COVID 2019 infections treatment -
Respiratory tract infections treatment moderate, severe

Subjects

  • Subject Type patients
  • Number

    Planned: 800

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

Patient Inclusion Criteria

- 18 years or older - Moderate to severe COVID-19 associated disease as defined by the WHO - Hospitalized patient - Willing and able to provide written informed consent prior to performing study procedures - Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay - Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen. - Febrile defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal documented within 48 hours of consent

Patient Exclusion Criteria

- Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation - SOFA >10 - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) - Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) - Pregnant women or women who are breastfeeding - Immunocompromised patients taking medication upon screening - Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

Trial Details

Identifiers

Identifier Owner
NCT04321993 ClinicalTrials.gov: US National Institutes of Health
SAIL004 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 17 Apr 2020

  • Primary Completion Dates

    Planned : 01 Feb 2022

  • End Dates

    Planned : 01 Mar 2022

Other Details

  • Design open; parallel; prospective
  • Phase of Trial Phase II
  • Location Canada
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
BaricitinibPrimary Drug Oral Tablet

Baricitinib

Drug: Baricitinib (janus kinase inhibitor) (Baricitinib 2 mg po daily for 10 days)

Clinical standard of care

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Barbara Goodall
(902) 292-0132 barbara.goodall@nshealth.ca
show details
-
Lisa Barrett
(902) 473-6446 lisa.barrett@nshealth.ca
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Dalhousie University
-
-
Lisa Barrett
-
-
Nova Scotia Health Authority
-
-
Nova Scotia Health Authority Halifax, Nova Scotia Canada

Trial History

Event Date Event Type Comment
27 Jul 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 27 Jul 2020
22 Jul 2020 Protocol amendment Number of arms changed from 3 to 2. Drug Lopinavir/ritonavir and experimental arm: Lopinavir/ritonavir removed from study protocol. Planned number of subjects also decreased. Updated 27 Jul 2020
22 Jul 2020 Other trial event Planned number of patients changed from 1000 to 800. Updated 27 Jul 2020
02 Jul 2020 Protocol amendment Number of arms changed from 4 to 3. Drug Hydroxychloroquine sulfate and experimental arm: Hydroxychloroquine sulfate removed from study protocol. Updated 27 Jul 2020
15 May 2020 Completion date Planned End Date changed from 1 Jul 2021 to 1 Mar 2022. Updated 20 May 2020
15 May 2020 Other trial event Planned primary completion date changed from 1 Feb 2021 to 1 Feb 2022. Updated 20 May 2020
22 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 27 Apr 2020
04 Apr 2020 Other trial event Planned initiation date changed from 1 Mar 2020 to 1 Apr 2020. Updated 08 Apr 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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