A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
- Conditions
- ovel Coronavirus Infectious Disease (COVID-19)
- Registration Number
- JPRN-jRCT2031190264
- Lead Sponsor
- Ohmagari Norio
- Brief Summary
The data show that remdesivir was superior to placebo in shortening the recovery time in adults hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Although serious adverse events occurred in 131 of 532 patients (24.6%) in the remdesivir group and 163 of 516 patients (31.6%) in the placebo group, no deaths were considered by the investigators to be related to treatment assignment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1114
1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.
2.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
3.Understands and agrees to comply with planned study procedures.
4.Agrees to the collection of oropharyngeal (OP) swabs.
5.Male or non-pregnant female adult =>18 years of age at time of enrollment.
6.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.
Note - 72 hours is not necessarily time from initial diagnosis. If => 72 hours since positive PCR, the PCR may be repeated to assess eligibility.
7.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
-Requiring supplemental oxygen, OR
-Requiring mechanical ventilation.
8.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
9.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2.
1.ALT/AST > 5 times the upper limit of normal.
2.Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis.
3.Pregnancy or breast feeding.
4.Anticipated transfer to another hospital which is not a study site within 72 hours.
5.Allergy to any study medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method