Remdesivir in treatment of COVID-19

Phase 2

Recruiting

• Conditions: COVID-19.; Clinically-epidemiologically diagnosed COVID-19, Probable COVID-19, Suspected COVID-19; U07.1

• Registration Number: IRCT20171122037571N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Ablility to fully understand, willingness to participate, and signing the informed consent form (in case of decreased level of consciousness or/ and cognitive impairment, informed consent is obtained from their legal representative)
Ages over 18 years
Patients with a definitive diagnosis of SARS-CoV-2 virus based on PCR with specific pulmonary involvement in radiography who have progressive hospital course (SpO2 <85% or RR > 30) despite receiving standard of care treatment protocols within 72 hours

Exclusion Criteria

Participants in any other clinical trial for COVID-19
Concomitant treatment with other antiviral drugs other than those recommended in the national protocol
Patients undergoing mechanical ventilation at the time of baseline
Evidence of multiorgan failure in the patient's clinical record based on the physician's diagnosis
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times the upper limit of normal (ULN)
Creatinine clearance less than 50 ml/min
The presence of any concurrent major diseases including malignancy, advanced heart failure, cirrhosis, chronic kidney disease, stroke, Alzheimer's, chronic progressive neurological diseases, etc.
Pregnant and lactating women
Possibility of being transferred to another hospital with no access to the study drug (for any reason)

Study & Design

• Study Type: interventional
• Study Design: Not specified