Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal

COVID-19 Clinical Trial

— CPT-R-Nepal  

Official title:

Compassionate Use of Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Prospective Observational Study (Amended Protocol)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570982
• Other study ID #: NHRC2020-001
• Status: Recruiting
• Start date: July 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: Nepal Health Research Council
• Contact: Janak Koirala, MD, MPH
• Phone: +977 9818762117
• Email: clinicaltrialsnepal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Nepal	Narayani Hospital	Birgunj
Nepal	Seti Provincial Hospital	Dhangadi
Nepal	BP Koirala Institute of Health Sciences (BPKIHS)	Dharan Bazar
Nepal	Sukraraj Tropical Disease Hospital	Kathmandu
Nepal	TU Teaching Hospital	Kathmandu
Nepal	Bheri Provincial Hospital	Nepalgunj

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Pradip Gyanwali,MD	Ministry of Health and Population, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

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