Status:
UNKNOWN
Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Registry Study
Lead Sponsor:
Nepal Health Research Council
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
The pandemic COVID-19 does not have an established treatment. Clinical trials of antiviral drugs against SARS CoV-2 are currently in progress. Clinical study done by NIH which included 1059 patients i...
Detailed Description
The pandemic COVID-19 does not have an established treatment. Although small studies have demonstrated some successes of few antiviral and immunomodulatory agents, either their data so far are not ver...
Eligibility Criteria
Inclusion
- All patients who receive treatment with CPT or Remdesivir will be eligible for the study. Treatment decision will be based on decision of the treating physicians. However, following guidelines for treatment are provided based on current standard of care: For Remdesivir: Patients with severe COVID-19 infection who require to be on oxygen supplementation.
- For convalescent plasma therapy: Patients who meet one of the following criteria are likely to benefit from convalescent plasma therapy:
- Patients on life-threatening COVID-19 infection when combined with Remdesivir.
- Patients who progress to life-threatening infection despite being on remdesivir for 48 hours or longer. The following definitions are used to define severe and life threatening COVID-19 infection.
- Severe COVID-19 infection is defined by one or more of the following criteria:
- Shortness of breath (dyspnea)
- Respiratory frequency ≥ 30/min
- Blood oxygen saturation ≤ 93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
- Lung infiltrates increased more than 50% within 24 to 48 hours
- Life-threatening COVID-19 infection is defined as one or more of the following:
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure
Exclusion
- If the diagnosis is not confirmed with PCR or similar alternative tests for COVID-19 infection
- Any patient with contraindications for receiving plasma transfusion should not receive plasma
- Any patient with contraindications for receiving Remdesivir should not receive Remdesivir
Key Trial Info
Start Date :
November 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 19 2021
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04669990
Start Date
November 19 2020
End Date
November 19 2021
Last Update
December 17 2020
Active Locations (4)
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1
Narayani Hospital
Birgunj, Nepal
2
Seti Provincial Hospital
Dhangadi, Nepal
3
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Nepal
4
Bheri Provincial Hospital
Nepalgunj, Nepal