COVID-19 Clinical Trial
Official title:
Compassionate Use of Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Prospective Observational Study (Amended Protocol)
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
| Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
| Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
| Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
| Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
| Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
| Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
| Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
| Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|