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Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Registry Study

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ClinicalTrials.gov Identifier: NCT04669990
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Pradip Gyanwali,MD, Nepal Health Research Council

Study Description
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Brief Summary:
The pandemic COVID-19 does not have an established treatment. Clinical trials of antiviral drugs against SARS CoV-2 are currently in progress. Clinical study done by NIH which included 1059 patients indicated that those who received Remdesivir had a median recovery time of 11 days as compared with 15 days in those who received placebo. Remdesivir has recently received full approval for COVID-19 by US FDA, and emergency use authorization (EUA) by multiple countries including European Commission and Indian Health Service. Remdesivir appears to demonstrate the most benefit in those with severe COVID-19 on supplemental oxygen. The NIH Panel recommends using Remdesivir for 5 days or until hospital discharge, whichever comes first. The interim analysis of WHO's SOLIDARITY trial, however, failed to show mortality benefit with Remdesivir. Review of literature suggests the transfusion of convalescent plasma has been used successfully in observational and retrospective studies. A recent metanalysis showed that convalescent plasma reduced mortality by 57% compared to matched-patients receiving standard treatments. The objective of NHRC sponsored initial clinical study protocol (Convalescent Plasma study) was to provide a coordinated approach for collection and preparation, distribution and guidance for safe and effective administration of convalescent plasma with antibodies against SAR CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment. On August 9th, 2020, the Government of Nepal gave permission to use Remdesivir in COVID-19 patients of Nepal only as a study drug when the original protocol was amended to add a second study arm to use Remdesivir for treatment of patients with moderate to severe COVID-19. The enrollment goal of these two protocols have been reached and collection of study data will be completed by the end of October 2020. On October 18th, the GoN MoHP also announced and directed to provide access for Remdesivir directly through the pharmacies. Therefore, this registry study has been designed to replace the compassionate use study of Remdesivir and Convalescent plasma.

Condition or disease Intervention/treatment
Covid19 Drug: Remdesivir

Detailed Description:
The pandemic COVID-19 does not have an established treatment. Although small studies have demonstrated some successes of few antiviral and immunomodulatory agents, either their data so far are not very encouraging (e.g. Hydroxychloroquine and Antiretroviral Protease Inhibitors) or clinical trials of newly introduced drugs are currently in progress and not available in Nepal. Review of literature suggests the transfusion of convalescent plasma has been used successfully in small observational and retrospective studies. A recent metanalysis showed that convalescent plasma reduced mortality by 57% compared to matched-patients receiving standard treatments. While multiple antiviral drugs are undergoing clinical trials and there is no established antiviral agents against COVID-19, the infectious diseases guidelines suggest use of Remdesivir among hospitalized patients with severe COVID-19 patients (Conditional recommendation, moderate certainty of evidence). Clinical study done by NIH which included 1059 patients indicated that those who received Remdesivir had a median recovery time of 11 days as compared with 15 days in those who received placebo. Remdesivir has received emergency use authorization for COVID-19 by US FDA, European Commission, and Indian Health Service. Remdesivir appears to demonstrate the most benefit in those with severe COVID-19 on supplemental oxygen. The NIH Panel recommends using Remdesivir for 5 days or until hospital discharge, whichever comes first. The interim analysis of WHO's SOLIDARITY trial, however, failed to show mortality benefit with Remdesivir.The objective of initial clinical protocol (Convalescent Plasma study) was to provide a coordinated approach for collection and preparation, distribution and guidance for safe and effective administration of convalescent plasma with antibodies against SAR CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment. On August 9th, 2020, the Government of Nepal gave permission to use Remdesivir in COVID-19 patients of Nepal only as a study drug when the original protocol was been amended to add a second study arm for use of Remdesivir for treatment of patients with moderate to severe COVID-19. The enrollment goal of these two protocols have been reached and collection of study data will be completed by the end of October 2020. On October 18th, the GoN MoHP also announced and directed to provide access for Remdesivir directly through the pharmacies. Therefore, this registry study has been designed to replace the compassionate use study of Remdesivir and Convalescent plasma.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Registry Study
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : November 19, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Remdesivir
    The objective of this Registry study is to continue to collect safety and outcome data for COVID-19 patients who are treated with Remdesivir and convalescent plasma therapy (CPT).
    Other Name: Convalescent Plasma

Outcome Measures
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Primary Outcome Measures :
  1. Demographics of recipients [ Time Frame: 9 Months ]
    - type of patients receiving plasma therapy : Age in Years, Sex: M/F

  2. Co-morbidity of recipient [ Time Frame: 9 Months ]
    - recipient comorbidities: Smoking, Diabetes, Heart disease, Chronic lung disease, chronic liver disease, cancer, organ transplant, HIV infection, TB. HIV, HBV, HCV, Syphillis

  3. Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy [ Time Frame: 9 Months ]
    • 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

  4. Hospital and ICU length of stay [ Time Frame: 9 Months ]
    - number of days of hospital stay and ICU stay

  5. Disposition of patients including survival [ Time Frame: 9 Months ]
    - condition at discharge: complete recovery, partial recovery with complications, death


Eligibility Criteria
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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

Inclusion Criteria:

  • All patients who receive treatment with CPT or Remdesivir will be eligible for the study. Treatment decision will be based on decision of the treating physicians. However, following guidelines for treatment are provided based on current standard of care: For Remdesivir: Patients with severe COVID-19 infection who require to be on oxygen supplementation.

For convalescent plasma therapy: Patients who meet one of the following criteria are likely to benefit from convalescent plasma therapy:

  1. Patients on life-threatening COVID-19 infection when combined with Remdesivir.
  2. Patients who progress to life-threatening infection despite being on remdesivir for 48 hours or longer. The following definitions are used to define severe and life threatening COVID-19 infection.

Severe COVID-19 infection is defined by one or more of the following criteria:

  1. Shortness of breath (dyspnea)
  2. Respiratory frequency ≥ 30/min
  3. Blood oxygen saturation ≤ 93%
  4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
  5. Lung infiltrates increased more than 50% within 24 to 48 hours

Life-threatening COVID-19 infection is defined as one or more of the following:

  1. Respiratory failure
  2. Septic shock
  3. Multiple organ dysfunction or failure

Exclusion Criteria:

  1. If the diagnosis is not confirmed with PCR or similar alternative tests for COVID-19 infection
  2. Any patient with contraindications for receiving plasma transfusion should not receive plasma
  3. Any patient with contraindications for receiving Remdesivir should not receive Remdesivir
Contacts and Locations
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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): NCT04669990


Contacts
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Contact: Janak Koirala, MD,MPH 9818762117 ext +977 clinicaltrialsnepal@gmail.com
Contact: Saroj Bhattarai, M.Sc 9840388970 ext +977 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         
Bheri Provincial Hospital Recruiting
Nepalgunj, Nepal
Contact: Rajan Pandey, MD         
Sponsors and Collaborators
Nepal Health Research Council
More Information
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Responsible Party: Dr. Pradip Gyanwali,MD, Member-Secretary, Nepal Health Research Council
ClinicalTrials.gov Identifier: NCT04669990    
Other Study ID Numbers: 749-2020
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents