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Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal

NCT04570982 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-09-30

No results posted yet for this study

Summary

The objective of this compassionate use study is to provide access and evaluate the outcome of Remdesivir and COVID-19 convalescent plasma use in patients with COVID-19. This protocol provides a coordinated approach for distribution and guidance for safe and effective administration of Remdesivir and convalescent plasma with antibodies against SARS CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them for the following specific objectives and outcomes:

SPECIFIC OBJECTIVES

1. Provide access to convalescent plasma for hospitalized patients with severe COVID-19 infection (compassionate use, expanded access program)
2. Monitor safety of the therapy with convalescent plasma containing antibodies against SAR CoV-2 and Remdesivir for hospitalized patients with severe COVID-19 infection
3. Evaluate outcomes in patients who received convalescent COVID-19 plasma therapy alone, Remdesivir alone, and both agents.

Study Design: This study will be a prospective, observational clinical study with an intention-to-treat, cross-over design. Comparison groups will be patients who received convalescent plasma vs. those who received Remdesivir. In addition, cross-over to convalescent plasma arm will be allowed for patients who continued to get worse even after receiving Remdesivir for more than 48 hours.

Conditions

Interventions

BIOLOGICAL

Convalescent Plasma

The objective of this protocol is to provide a coordinated approach for distribution and guidance for safe and effective administration of convalescent serum with antibodies against SAR CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them.

Sponsors & Collaborators

  • Ministry of Health and Population, Nepal

    collaborator OTHER_GOV

  • Dr. Pradip Gyanwali,MD

    lead OTHER_GOV

Principal Investigators

  • Pradip Gyanwali, MD · Nepal Health Research Council

  • Meghnath Dhimal, PhD · Nepal Health Research Council

  • Janak Koirala, MD, MPH · Nepal Health Research Council

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-10-30
Completion
2020-12-30
FDA Drug
Yes

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570982 on ClinicalTrials.gov