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To Study the safety of Remdesivir in COVID-19 Patients.

Adverse Drug Reaction profile of Remdesivir in COVID-19 patients: A Cohort Event Monitoring Study. - CEMS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028487
Enrollment
100
Registered
2020-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 3: J128- Other viral pneumonia

Interventions

None listed

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2. Laboratory (RT-PCR) confirmed COVID-19. 3. Lung involvement confirmed with chest imaging 4. Hospitalized with a SaO2/SPO2 5. Willingness of study participant to take part in this study.

Exclusion criteria

Exclusion criteria: 3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

Design outcomes

Primary

MeasureTime frame
1. To assess the frequency and pattern of subjective ADRs. 2. To analyse and interpret the objective ADRs through derangements in lab values. Timepoint: 3 months—

Secondary

MeasureTime frame
1. To correlate the appearance of ADRs of Remdesivir with various risk factors. 2.To collect and correlate any other therapy related event â?? having an impact on patient outcome and drug efficacy. Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Aakanksha Priya

AIIMS, Patna

drshrutis@aiimspatna.org7739277734

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026