Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal
NCT ID: NCT04570982
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-07-30
2020-12-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Convalescent Plasma with SOC
All patients will receive CPT and SOC
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Ministry of Health and Population, Nepal
OTHER_GOV
Dr. Pradip Gyanwali,MD
OTHER_GOV
Responsible Party
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Dr. Pradip Gyanwali,MD
Chief-Executive
Principal Investigators
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Pradip Gyanwali, MD
Role: STUDY_CHAIR
Nepal Health Research Council
Meghnath Dhimal, PhD
Role: STUDY_DIRECTOR
Nepal Health Research Council
Janak Koirala, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Nepal Health Research Council
Locations
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Narayani Hospital
Birgunj, , Nepal
Seti Provincial Hospital
Dhangadi, , Nepal
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, , Nepal
Sukraraj Tropical Disease Hospital
Kathmandu, , Nepal
TU Teaching Hospital
Kathmandu, , Nepal
Bheri Provincial Hospital
Nepalgunj, , Nepal
Countries
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Central Contacts
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Facility Contacts
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Uday N Singh, MD.
Role: primary
Sher B Kamar, MD.
Role: primary
Krishna Pokhrel, MD.
Role: primary
Anup Bastola, MD.
Role: primary
Santa K Das, MD.
Role: primary
Rajan Pandey, MD.
Role: primary
References
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Koirala J, Gyanwali P, Gerzoff RB, Bhattarai S, Nepal B, Manandhar R, Jha R, Sharma S, Sharma YR, Bastola A, Murphy H, Acharya S, Adhikari P, Rajkarnikari M, Vaidya KM, Panthi CL, Bista B, Giri G, Aryal S, Pant S, Pokharel A, Karki S, Basnet S, Koirala B, Dhimal M; Nepal COVID-19 Clinical Study Collaborators. Experience of Treating COVID-19 With Remdesivir and Convalescent Plasma in a Resource-Limited Setting: A Prospective, Observational Study. Open Forum Infect Dis. 2021 Aug 21;8(8):ofab391. doi: 10.1093/ofid/ofab391. eCollection 2021 Aug.
Other Identifiers
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NHRC2020-001
Identifier Type: -
Identifier Source: org_study_id