Real World COVID-19 Antiviral Effectiveness Research (myRECOVER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

• Study Contact: Name: Ee Vien Low, Ph.D.; Phone Number: +60333628829; Email: evlow@moh.gov.my
• Study Contact Backup: Name: Mohan Dass Pathamanathan, MD; Phone Number: +60333628628; Email: drmohandass@moh.gov.my

Study Locations

• Malaysia
  • Petaling Jaya, Malaysia
    • Recruiting
    • Klinik Kesihatan Taman Medan
    • Contact: Ee Vien Low
    • Contact: Suet Yin Chow
    • Principal Investigator: Suet Yin Chow
  • Selangor
    • Kajang, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Kajang
      • Contact: Lih Bing Lau
      • Contact: Mohan Dass Pathmanathan
      • Principal Investigator: Lih Bing Lau
      • Sub-Investigator: Siti Rohani Mohamed Alias
    • Klang, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Banadar Botanik
      • Contact: Salbiah Mohamed Isa
      • Contact: Cheng Lee Ooi
      • Principal Investigator: Salbiah Mohamed Isa
    • Klang, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Bukit Kuda
      • Contact: Siti Fairuz
      • Contact: Ee Vien Low
      • Principal Investigator: Siti Fairuz
    • Klang, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Pandamaran
      • Contact: Cheng Lee Ooi
      • Contact: Zienna Zufida Zainol Rashid
      • Principal Investigator: Zienna Zufida Zainol Rashid
    • Petaling Jaya, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Seksyen 19
      • Contact: Cheng Lee Ooi
      • Contact: Mohammad Ariff Fahmi Ahmad Zawawi
      • Principal Investigator: Mohammad Ariff Fahmi Ahmad Zawawi
    • Petaling Jaya, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Seksyen 7
      • Contact: Cheng Lee Ooi
      • Contact: Azah Abdul Samad
      • Principal Investigator: Azah Abdul Samad
    • Subang Jaya, Selangor, Malaysia
      • Recruiting
      • Klinik Kesihatan Puchong Batu 14
      • Contact: Ee Vien Low
      • Contact: Izwan Effendy Ismail
      • Principal Investigator: Izwan Effendy Ismail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and proportion of study participants with COVID-19 related Hospitalization	Hospital admission due to COVID-19	Within 28 days after treatment initiation
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Duration of Hospitalization	Number of days hospitalized due to COVID-19	Within 28 days after treatment initiation
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: oral antivirals; high risk patients
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: NMRR ID-22-00938-2YN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No