Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Remdesivir
-
No. randomised (N): 279
-
Participants with laboratory confirmed COVID-19 (%):
-
Participants with mild illness (%): 100
-
Participants with mild or moderate illness (%):
-
Participants with moderate illness (%):
-
Participants with moderate to severe illness (%):
-
Participants with severe illness (%):
-
Participants with severe or critical illness (%):
-
Participants with critical illness (%):
-
Age (mean [range]): 50
-
Female participants (%): 47
-
Paediatric participants (%):
-
Pregnant participants (%):
-
Pregnant and/or breastfeeding participants (%):
-
Frailty index or similar:
-
Participants with hypertension (%): 49.5
-
Participants with diabetes (%): 62
-
Participants with chronic heart disease (%):
-
Participants with cancer (%): 4.3
-
Participants with dementia (%):
-
Participants with chronic lung disease/COPD (%): 24
-
Participants with cognitive impairment (%):
Placebo
-
No. randomised (N): 283
-
Participants with laboratory confirmed COVID-19 (%):
-
Participants with mild illness (%):
-
Participants with mild or moderate illness (%):
-
Participants with moderate illness (%):
-
Participants with moderate to severe illness (%):
-
Participants with severe illness (%):
-
Participants with severe or critical illness (%):
-
Participants with critical illness (%):
-
Age (mean [range]): 51
-
Female participants (%): 48.8
-
Paediatric participants (%):
-
Pregnant participants (%):
-
Pregnant and/or breastfeeding participants (%):
-
Frailty index or similar:
-
Participants with hypertension (%): 45.9
-
Participants with diabetes (%): 61.1
-
Participants with chronic heart disease (%):
-
Participants with cancer (%): 6.4
-
Participants with dementia (%):
-
Participants with chronic lung disease/COPD (%): 24
-
Participants with cognitive impairment (%):
Overall
-
No. randomised (N):
-
Participants with laboratory confirmed COVID-19 (%):
-
Participants with mild illness (%):
-
Participants with mild or moderate illness (%):
-
Participants with moderate illness (%):
-
Participants with moderate to severe illness (%):
-
Participants with severe illness (%):
-
Participants with severe or critical illness (%):
-
Participants with critical illness (%):
-
Age (mean [range]):
-
Female participants (%):
-
Paediatric participants (%):
-
Pregnant participants (%):
-
Pregnant and/or breastfeeding participants (%):
-
Frailty index or similar:
-
Participants with hypertension (%):
-
Participants with diabetes (%):
-
Participants with chronic heart disease (%):
-
Participants with cancer (%):
-
Participants with dementia (%):
-
Participants with chronic lung disease/COPD (%):
-
Participants with cognitive impairment (%):
Included criteria: 12 years of age or olderand one preexisting risk factor for progression to severe Covid-19 or were 60 years of age or older, Eligible patients had at least one ongoing symptom consistent with Covid-19, with onset of the first symptom within 7 days before randomization
Excluded criteria: Patients were ineligible if they were receiving or were expected to receive supplemental oxygen or hospital care at the time of screening. Patients were also ineligible if they had had a previous hospitalization for Covid-19, had previously received treatment for Covid-19 (including investigational agents), or had received a SARSCoV-2 vaccine.
Pretreatment:
Intervention Characteristics
Remdesivir
-
Intervention (including dosage, route of administration, loading and maintenance phases): e intravenous remdesivir (200 mg on day 1 followed by100 mg on days 2 and 3)
-
Co-intervention (including description of standard care):
-
Duration of treatment (days): 3
-
Follow up after randomisation (days): 14
Placebo
-
Intervention (including dosage, route of administration, loading and maintenance phases):
-
Co-intervention (including description of standard care):
-
Duration of treatment (days): 3
-
Follow up after randomisation (days): 14
All-cause mortality (Day 28)
-
Outcome type: DichotomousOutcome
All-cause mortality (Day 14)
-
Outcome type: DichotomousOutcome
All-cause mortality (End of treatment)
-
Outcome type: DichotomousOutcome
Invasive mechanical ventilation or death
-
Outcome type: DichotomousOutcome
Invasive mechanical ventilation
-
Outcome type: DichotomousOutcome
Duration of invasive mechanical ventilation
-
Outcome type: ContinuousOutcome
NIV / HFNO
-
Outcome type: DichotomousOutcome
Duration of NIV / HFNO
-
Outcome type: ContinuousOutcome
Supplemental oxygen
-
Outcome type: DichotomousOutcome
Duration of supplemental oxygen
-
Outcome type: ContinuousOutcome
Respiratory failure or ARDS
-
Outcome type: DichotomousOutcome
Serious adverse events
-
Outcome type: DichotomousOutcome
Adverse events
-
Outcome type: DichotomousOutcome
Discontinuation due to an adverse event
-
Outcome type: DichotomousOutcome
Septic shock
-
Outcome type: DichotomousOutcome
Dyspnea / breathlessness resolution
-
Outcome type: DichotomousOutcome
Hospitalisation
-
Outcome type: DichotomousOutcome
ICU admission
-
Outcome type: DichotomousOutcome
Duration of hospital stay
-
Outcome type: ContinuousOutcome
Discharge from hospital
-
Outcome type: DichotomousOutcome
Virological clearance (negative PCR)
-
Outcome type: DichotomousOutcome
Clinical recovery
-
Outcome type: DichotomousOutcome
Time to recovery
-
Outcome type: ContinuousOutcome
Clinical improvement
-
Outcome type: DichotomousOutcome
Time to improvement
-
Outcome type: ContinuousOutcome
Clinical deterioration
-
Outcome type: DichotomousOutcome
Time to deterioration
-
Outcome type: ContinuousOutcome
Sponsorship source: Supported by Gilead Sciences
Country: United states
Setting: Outpatients
Comments:
Authors name: Dr. Gottlieb
Institution: Baylor University Medical Center
Email: robert.gottlieb@bswhealth.org
Address: Baylor University Medical Center, Center forAdvanced Heart and Lung Disease, 3410Worth St., Ste. 250, Dallas, TX 75246.
Clinical trial identifier: NCT04501952
Preprint or peer reviewed: Peer reviewed
Single centre or multi-centre (no. of centres): Multi-centre