NCT04570982

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. 1.Provide access to convalescent plasma for hospitalized patients with severe COVID-19 infection (compassionate use, expanded access program)
  2. 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. 3.Evaluate outcomes in patients who received convalescent COVID-19 plasma therapy alone, Remdesivir alone, and both agents.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

July 24, 2020

Last Update Submit

September 29, 2020

Conditions

COVID-19

Keywords

Convalescent PlasmaRemdesivir

Outcome Measures

Primary Outcomes (8)

  • Availability of convalescent plasma

    * percentage of donors who donated plasma versus those who were eligible for donation * percentage of patient who received plasma vs. requests received

    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

    * donor health status: HIV, HBV, HCV, Syphillis * Donor status: duration after recovery from COVID-19, plasma antibody titer against SARS CoV-2

    12 Weeks

  • Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy

    * 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

    12 Weeks

  • Hospital and ICU length of stay

    \- number of days of hospital stay and ICU stay

    12 Weeks

  • Disposition of patients including survival

    \- condition at discharge: complete recovery, partial recovery with complications, death

    12 Weeks

Study Arms (1)

Convalescent Plasma with SOC

All patients will receive CPT and SOC

Biological: Convalescent Plasma

Interventions

Convalescent PlasmaBIOLOGICAL

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.

Convalescent Plasma with SOC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from all COVID-19 treating hospitals of Nepal which are participating in this clinical study.

You may qualify if:

  • 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.

You may not qualify if:

  • Under 18 years of age
  • Not confirmed with PCR test for COVID-19 infection
  • Cases not meeting criteria for severe or life-threatening COVID-19 infection
  • Any patient with contraindications for receiving plasma transfusion will not receive plasma
  • Any patient with contraindications for receiving Remdesivir will not receive Remdesivir
  • Patient's declination to enroll in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Narayani Hospital

Birgunj, Nepal

RECRUITING

Seti Provincial Hospital

Dhangadi, Nepal

RECRUITING

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Nepal

RECRUITING

Sukraraj Tropical Disease Hospital

Kathmandu, Nepal

RECRUITING

TU Teaching Hospital

Kathmandu, Nepal

RECRUITING

Bheri Provincial Hospital

Nepalgunj, Nepal

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34430672DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pradip Gyanwali, MD

    Nepal Health Research Council

    STUDY CHAIR

  • Meghnath Dhimal, PhD

    Nepal Health Research Council

    STUDY DIRECTOR

  • Janak Koirala, MD, MPH

    Nepal Health Research Council

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janak Koirala, MD, MPH

CONTACT

+977 9818762117clinicaltrialsnepal@gmail.com

Saroj Bhattarai, MSc.

CONTACT

+977 9840388970bhattaraisaroj23@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief-Executive

Study Record Dates

First Submitted

July 24, 2020

First Posted

September 30, 2020

Study Start

July 30, 2020

Primary Completion

October 30, 2020

Study Completion

December 30, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NE(6)