Real World COVID-19 Antiviral Effectiveness Research

COVID-19 Clinical Trial

— myRECOVER  

Official title:

Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638919
• Other study ID #: NMRR ID-22-00938-2YN
• Status: Recruiting
• Start date: December 6, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2023
• Source: Clinical Research Centre, Malaysia
• Contact: Ee Vien Low, Ph.D.
• Phone: +60333628829
• Email: evlow[@]moh.gov.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: July 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Oral Antiviral
Nirmatrelvir plus ritonavir or molnupiravir

Locations

Country	Name	City	State
Malaysia	Klinik Kesihatan Kajang	Kajang	Selangor
Malaysia	Klinik Kesihatan Banadar Botanik	Klang	Selangor
Malaysia	Klinik Kesihatan Bukit Kuda	Klang	Selangor
Malaysia	Klinik Kesihatan Pandamaran	Klang	Selangor
Malaysia	Klinik Kesihatan Seksyen 19	Petaling Jaya	Selangor
Malaysia	Klinik Kesihatan Seksyen 7	Petaling Jaya	Selangor
Malaysia	Klinik Kesihatan Taman Medan	Petaling Jaya
Malaysia	Klinik Kesihatan Puchong Batu 14	Subang Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and proportion of study participants with COVID-19 related Hospitalization	Hospital admission due to COVID-19	Within 28 days after treatment initiation
Primary	Frequency and proportion of of study participants with COVID-19 related all-caused mortality	Any cause of death	Within 28 days after treatment initiation
Secondary	Frequency and proportion of study participants with of COVID-19 related symptoms	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)	Within 28 days after treatment initiation
Secondary	Frequency and proportion of study participants with COVID-19 ICU admission	Admission to Intensive Care Unit (ICU) due to COVID-19	Within 28 days after treatment initiation
Secondary	Frequency and proportion of study participants with adverse drug reaction	Medication related adverse reaction (eg. rash, itchiness, increased blood pressure, abdominal pain, etc)	Within 28 days after treatment initiation
Secondary	Duration of Hospitalization	Number of days hospitalized due to COVID-19	Within 28 days after treatment initiation
Secondary	Frequency and proportion of study participants with long-term COVID-19 symptoms	COVID-19 related symptoms that last more than 6 weeks	COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19