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myRECOVER: Real World COVID-19 Antiviral Effectiveness Research

Sponsor
Clinical Research Centre, Malaysia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638919
Collaborator
(none)
660
Enrollment
7.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a prospective observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions. In this study, we will observe the progress of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Antiviral

Detailed Description

This protocol is a prospective, multi-center, observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions in preventing progression of COVID-19 to severe COVID-19.

In this study, we will observe the clinical outcomes (COVID-19 symptoms, hospitalization admission, mortality, long term COVID-19 symptoms) of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic . The hypothesis is that oral antiviral is beneficial in preventing disease progression and reducing long term COVID-19 symptoms.

Study Design

Study Type:
Observational
Anticipated Enrollment :
660 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions
Anticipated Study Start Date :
Dec 6, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Oral Antiviral Group

Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19

Drug: Oral Antiviral
Nirmatrelvir plus ritonavir or molnupiravir
Other Names:
  • Paxlovid
  • Lagevrio

    		•
    Non Oral Antiviral Group

    Study participant not initiated with oral antiviral for the treatment of COVID-19

    Outcome Measures

    Primary Outcome Measures

    1. Frequency and proportion of study participants with COVID-19 related Hospitalization [Within 28 days after treatment initiation]

      Hospital admission due to COVID-19

    2. Frequency and proportion of of study participants with COVID-19 related all-caused mortality [Within 28 days after treatment initiation]

      Any cause of death

    Secondary Outcome Measures

    1. Frequency and proportion of study participants with of COVID-19 related symptoms [Within 28 days after treatment initiation]

      Type of COVID-19 related symptoms (Eg. fever or chills, fatigue, shortness of breath, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea)

    2. Frequency and proportion of study participants with COVID-19 ICU admission [Within 28 days after treatment initiation]

      Admission to Intensive Care Unit (ICU) due to COVID-19

    3. Frequency and proportion of study participants with adverse drug reaction [Within 28 days after treatment initiation]

      Medication related adverse reaction (eg. rash, itchiness, increased blood pressure, abdominal pain, etc)

    4. Duration of Hospitalization [Within 28 days after treatment initiation]

      Number of days hospitalized due to COVID-19

    5. Frequency and proportion of study participants with long-term COVID-19 symptoms [COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19]

      COVID-19 related symptoms that last more than 6 weeks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.
    Exclusion Criteria:
    • Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Clinical Research Centre, Malaysia

    Investigators

    • Principal Investigator: Ee Vien Low, Ph.D., Clinical Research Center, Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinical Research Centre, Malaysia
    ClinicalTrials.gov Identifier:
    NCT05638919
    Other Study ID Numbers:
    • NMRR ID-22-00938-2YN
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clinical Research Centre, Malaysia
    oral antivirals
    high risk patients
    Additional relevant MeSH terms:
    COVID-19
    Antiviral Agents

    Study Results

    No Results Posted as of Dec 6, 2022