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| Name | Class |
|---|---|
| Ministry of Health and Population, Nepal | OTHER_GOV |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma with SOC | All patients will receive CPT and SOC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Availability of convalescent plasma |
| 12 Weeks |
| Amount of Plasma | - amount of plasma administered per patient | 12 Weeks |
| Demographics of recipients | - type of patients receiving plasma therapy : Age in Years, Sex: M/F, | 12 Weeks |
| 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 |
| Donor status |
| 12 Weeks |
| Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy |
| 12 Weeks |
| Hospital and ICU length of stay | - number of days of hospital stay and ICU stay | 12 Weeks |
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A. INCLUSION CRITERIA
All patients:
Minimum 18 years of age
Laboratory-confirmed diagnosis of COVID-19 infection with PCR test positive for SARS-CoV-2
Hospitalized patients admitted to an acute care facility for the treatment of COVID-19
Signed informed consent provided by the patient or patient's healthcare proxy
For Remdesivir:
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:
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
Patients who progress to severe or life threatening infection despite being on remdesivir for 48 hours or longer.
B. EXCLUSION CRITERIA
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Patients will be recruited from all COVID-19 treating hospitals of Nepal which are participating in this clinical study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janak Koirala, MD, MPH | Contact | +977 9818762117 | clinicaltrialsnepal@gmail.com | |
| Saroj Bhattarai, MSc. | Contact | +977 9840388970 | bhattaraisaroj23@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pradip Gyanwali, MD | Nepal Health Research Council | Study Chair |
| Meghnath Dhimal, PhD | Nepal Health Research Council | Study Director |
| Janak Koirala, MD, MPH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narayani Hospital | Recruiting | Birgunj | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34430672 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Disposition of patients including survival | - condition at discharge: complete recovery, partial recovery with complications, death | 12 Weeks |
| Nepal Health Research Council |
| Principal Investigator |
| Seti Provincial Hospital | Recruiting | Dhangadi | Nepal |
|
| BP Koirala Institute of Health Sciences (BPKIHS) | Recruiting | Dharān | Nepal |
|
| Sukraraj Tropical Disease Hospital | Recruiting | Kathmandu | Nepal |
|
| TU Teaching Hospital | Recruiting | Kathmandu | Nepal |
|
| Bheri Provincial Hospital | Recruiting | Nepalgunj | Nepal |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |