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.
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.
A. INCLUSION CRITERIA
All patients:
1. Minimum 18 years of age
2. Laboratory-confirmed diagnosis of COVID-19 infection with PCR test positive for
SARS-CoV-2
3. Hospitalized patients admitted to an acute care facility for the treatment of COVID-19
4. Signed informed consent provided by the patient or patient's healthcare proxy
For Remdesivir:
5. Moderate to severe COVID-19 infection who require to be on oxygen supplementation
For convalescent plasma therapy:
A patient has to meet one of the following criteria to be eligible for receiving
convalescent plasma therapy:
6. Severe or life-threatening COVID-19 infection, or judged by the treating provider to
be at high risk of progression to severe or life-threatening disease
7. Patients who progress to severe or life threatening infection despite being on
remdesivir for 48 hours or longer.
B. EXCLUSION CRITERIA
1. Under 18 years of age
2. Not confirmed with PCR test for COVID-19 infection
3. Cases not meeting criteria for severe or life-threatening COVID-19 infection
4. Any patient with contraindications for receiving plasma transfusion will not receive
plasma
5. Any patient with contraindications for receiving Remdesivir will not receive
Remdesivir
6. Patient's declination to enroll in the study
Narayani Hospital
Birgunj, Nepal
Seti Provincial Hospital
Dhangadi, Nepal
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān Bāzār, Nepal
Sukraraj Tropical Disease Hospital
Kathmandu, Nepal
TU Teaching Hospital
Kathmandu, Nepal
Bheri Provincial Hospital
Nepalgunj, Nepal
Janak Koirala, MD, MPH
+977 9818762117
clinicaltrialsnepal@gmail.com
Saroj Bhattarai, MSc.
+977 9840388970
bhattaraisaroj23@gmail.com