COVID-19 Clinical Trial
Official title:
Compassionate Use of Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Prospective Observational Study (Amended Protocol)
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.
ENROLLMENT Patients will be recruited from all COVID-19 treating hospitals of Nepal which are
participating in this clinical study. All hospitalized patients with moderate to severe
COVID-19 infection will be screened for Remdesivir Treatment and those with severe to life
threatening COVID-19 infection will be screened for Convalescent plasma therapy.
Donors Convalescent plasma donors will be recruited from the record of the hospitals from
where they were discharged. The COVID hospitals will be asked to collect names of recovered
patients who have voluntarily shown interest to donate plasma. When possible donated plasma
will be stored in respective hospitals or blood bank.
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