Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal

• Conditions: COVID-19
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04570982
• Lead Sponsor: Dr. Pradip Gyanwali,MD

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-07-24
• Study Start: 2020-07-30
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma with SOC	Convalescent Plasma	All patients will receive CPT and SOC

Primary Outcome Measures

Name	Time	Method
Hospital and ICU length of stay	12 Weeks	- number of days of hospital stay and ICU stay
Demographics of recipients	12 Weeks	- type of patients receiving plasma therapy : Age in Years, Sex: M/F,
Co-morbidity of recipient	12 Weeks	- recipient comorbidities: Smoking, Diabetes, Heart disease, Chronic lung disease, chronic liver disease, cancer, organ transplant, HIV infection, TB. HIV, HBV, HCV, Syphillis
Availability of convalescent plasma	12 Weeks	* percentage of donors who donated plasma versus those who were eligible for donation; * percentage of patient who received plasma vs. requests received
Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy	12 Weeks	* any expected and unexpected adverse events during or after treatment (upto 7 days); * any other complications related or unrelated to plasma transfusion and Remdesivir during hospital stay
Amount of Plasma	12 Weeks	- amount of plasma administered per patient
Donor status	12 Weeks	* donor health status: HIV, HBV, HCV, Syphillis; * Donor status: duration after recovery from COVID-19, plasma antibody titer against SARS CoV-2
Disposition of patients including survival	12 Weeks	- condition at discharge: complete recovery, partial recovery with complications, death

Trial Locations

Locations (6)

Narayani Hospital; 🇳🇵 Birgunj, Nepal

Sukraraj Tropical Disease Hospital; 🇳🇵 Kathmandu, Nepal

Seti Provincial Hospital; 🇳🇵 Dhangadi, Nepal

TU Teaching Hospital; 🇳🇵 Kathmandu, Nepal

BP Koirala Institute of Health Sciences (BPKIHS); 🇳🇵 Dharān Bāzār, Nepal

Bheri Provincial Hospital; 🇳🇵 Nepalgunj, Nepal