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

December 15, 2020 updated by: Dr. Pradip Gyanwali,MD, Nepal Health Research Council
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Nepal
      • Birgunj, Nepal
        • Recruiting
        • Narayani Hospital
        • Contact:
          • Uday N Singh, MD
      • Dhangadi, Nepal
        • Recruiting
        • Seti Provincial Hospital
        • Contact:
          • Sher B Kamar, MD
      • Dharān Bāzār, Nepal
        • Recruiting
        • BP Koirala Institute of Health Sciences (BPKIHS)
        • Contact:
          • Krishna Pokhrel, MD
      • Nepalgunj, Nepal
        • Recruiting
        • Bheri Provincial Hospital
        • Contact:
          • Rajan Pandey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographics of recipients
Time Frame: 9 Months
- type of patients receiving plasma therapy : Age in Years, Sex: M/F
9 Months
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
9 Months
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
9 Months
Hospital and ICU length of stay
Time Frame: 9 Months
- number of days of hospital stay and ICU stay
9 Months
Disposition of patients including survival
Time Frame: 9 Months
- condition at discharge: complete recovery, partial recovery with complications, death
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nepal Health Research Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 749-2020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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