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Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal (CPT-R-Nepal)

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ClinicalTrials.gov Identifier: NCT04570982
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Ministry of Health and Population, Nepal
Information provided by (Responsible Party):
Dr. Pradip Gyanwali,MD, Nepal Health Research Council

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.


Condition or disease Intervention/treatment
COVID-19 Biological: Convalescent Plasma

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Compassionate Use of Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Prospective Observational Study (Amended Protocol)
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Group/Cohort Intervention/treatment
Convalescent Plasma with SOC
All patients will receive CPT and SOC
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.




Primary Outcome Measures :
  1. Availability of convalescent plasma [ Time Frame: 12 Weeks ]
    • percentage of donors who donated plasma versus those who were eligible for donation
    • percentage of patient who received plasma vs. requests received

  2. Amount of Plasma [ Time Frame: 12 Weeks ]
    - amount of plasma administered per patient

  3. Demographics of recipients [ Time Frame: 12 Weeks ]
    - type of patients receiving plasma therapy : Age in Years, Sex: M/F,

  4. Co-morbidity of recipient [ Time Frame: 12 Weeks ]
    - recipient comorbidities: Smoking, Diabetes, Heart disease, Chronic lung disease, chronic liver disease, cancer, organ transplant, HIV infection, TB. HIV, HBV, HCV, Syphillis

  5. Donor status [ Time Frame: 12 Weeks ]
    • donor health status: HIV, HBV, HCV, Syphillis
    • Donor status: duration after recovery from COVID-19, plasma antibody titer against SARS CoV-2

  6. Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy [ Time Frame: 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

  7. Hospital and ICU length of stay [ Time Frame: 12 Weeks ]
    - number of days of hospital stay and ICU stay

  8. Disposition of patients including survival [ Time Frame: 12 Weeks ]
    - condition at discharge: complete recovery, partial recovery with complications, death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from all COVID-19 treating hospitals of Nepal which are participating in this clinical study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570982


Contacts
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Contact: Janak Koirala, MD, MPH +977 9818762117 clinicaltrialsnepal@gmail.com
Contact: Saroj Bhattarai, MSc. +977 9840388970 bhattaraisaroj23@gmail.com

Locations
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Nepal
Narayani Hospital Recruiting
Birgunj, Nepal
Contact: Uday N Singh, MD.         
Seti Provincial Hospital Recruiting
Dhangadi, Nepal
Contact: Sher B Kamar, MD.         
BP Koirala Institute of Health Sciences (BPKIHS) Recruiting
Dharān Bāzār, Nepal
Contact: Krishna Pokhrel, MD.         
Sukraraj Tropical Disease Hospital Recruiting
Kathmandu, Nepal
Contact: Anup Bastola, MD.         
TU Teaching Hospital Recruiting
Kathmandu, Nepal
Contact: Santa K Das, MD.         
Bheri Provincial Hospital Recruiting
Nepalgunj, Nepal
Contact: Rajan Pandey, MD.         
Sponsors and Collaborators
Dr. Pradip Gyanwali,MD
Ministry of Health and Population, Nepal
Investigators
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Study Chair: Pradip Gyanwali, MD Nepal Health Research Council
Study Director: Meghnath Dhimal, PhD Nepal Health Research Council
Principal Investigator: Janak Koirala, MD, MPH Nepal Health Research Council
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Pradip Gyanwali,MD, Chief-Executive, Nepal Health Research Council
ClinicalTrials.gov Identifier: NCT04570982    
Other Study ID Numbers: NHRC2020-001
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Pradip Gyanwali,MD, Nepal Health Research Council:
Convalescent Plasma
Remdesivir
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases