COVID-19myRECOVERNCT05638919
Real World COVID-19 Antiviral Effectiveness Research
An observational study of COVID-19, run by Clinical Research Centre, Malaysia at 8 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Oral Antiviral
- Type of treatment
- Pill or oral medicine
- How many people
- 660 participants
- Where
- 8 sitesMalaysia
- Study dates
- 6 Dec 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions
Who may be able to join
- All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.
Who cannot join
- Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Malaysia8 sites, 8 recruiting
- Recruiting
Klinik Kesihatan Kajang
Kajang, Selangor
Lih Bing Lau
Mohan Dass Pathmanathan
- Recruiting
Klinik Kesihatan Banadar Botanik
Klang, Selangor
Salbiah Mohamed Isa
Cheng Lee Ooi
- Recruiting
Klinik Kesihatan Bukit Kuda
Klang, Selangor
Siti Fairuz
Ee Vien Low
- Recruiting
Klinik Kesihatan Pandamaran
Klang, Selangor
Zienna Zufida Zainol Rashid
Cheng Lee Ooi
- Recruiting
Klinik Kesihatan Seksyen 19
Petaling Jaya, Selangor
Mohammad Ariff Fahmi Ahmad Zawawi
Cheng Lee Ooi
- Recruiting
Klinik Kesihatan Seksyen 7
Petaling Jaya, Selangor
Azah Abdul Samad
Cheng Lee Ooi
- Recruiting
Klinik Kesihatan Taman Medan
Petaling Jaya
Suet Yin Chow
Ee Vien Low
- Recruiting
Klinik Kesihatan Puchong Batu 14
Subang Jaya, Selangor
Izwan Effendy Ismail
Ee Vien Low
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Oral Antiviral
- Keywords
- oral antivirals, high risk patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AntiviralDrug
Also called Paxlovid, Lagevrio
Nirmatrelvir plus ritonavir or molnupiravir
| Study group | Role | What they receive |
|---|---|---|
| Oral Antiviral Group | Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19 Receives: Drug: Oral Antiviral | |
| Non Oral Antiviral Group | Study participant not initiated with oral antiviral for the treatment of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and proportion of study participants with COVID-19 related Hospitalization
Hospital admission due to COVID-19
Measured: Within 28 days after treatment initiation
Frequency and proportion of of study participants with COVID-19 related all-caused mortality
Any cause of death
Measured: Within 28 days after treatment initiation
Secondary outcomes (5)
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)
Measured: 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
Measured: 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)
Measured: Within 28 days after treatment initiation
Duration of Hospitalization
Number of days hospitalized due to COVID-19
Measured: 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
Measured: COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start6 Dec 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ee Vien Low, Ph.D., Principal investigator, Clinical Research Center, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638919
- Sponsor's protocol ID
- NMRR ID-22-00938-2YN
- Acronym
- myRECOVER
- Status last verified
- May 2023
- First submitted
- 4 Dec 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions
- ClinicalTrials.gov ID
- NCT05638919
- Acronym / sponsor ID
- myRECOVER / NMRR ID-22-00938-2YN
- Conditions
- COVID-19
- Keywords
- oral antivirals, high risk patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antiviral Group | – | Drug: Oral AntiviralStudy participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19 |
| Non Oral Antiviral Group | – | –Study participant not initiated with oral antiviral for the treatment of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All SARS-CoV-2 positive adult population seen in the Ministry of Health Malaysia institutions
Key inclusion criteria (1 listed)
- All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.
Key exclusion criteria (1 listed)
- Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral AntiviralAlso: Paxlovid, LagevrioNirmatrelvir plus ritonavir or molnupiravir | Drug | Oral Antiviral Group |
Primary outcome
Frequency and proportion of study participants with COVID-19 related Hospitalization
Time frame: Within 28 days after treatment initiation
Hospital admission due to COVID-19
Frequency and proportion of of study participants with COVID-19 related all-caused mortality
Time frame: Within 28 days after treatment initiation
Any cause of death
5 secondary outcomes
Frequency and proportion of study participants with of COVID-19 related symptoms
Time frame: Within 28 days after treatment initiation
Frequency and proportion of study participants with COVID-19 ICU admission
Time frame: Within 28 days after treatment initiation
Frequency and proportion of study participants with adverse drug reaction
Time frame: Within 28 days after treatment initiation
Duration of Hospitalization
Time frame: Within 28 days after treatment initiation
Frequency and proportion of study participants with long-term COVID-19 symptoms
Time frame: COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ee Vien Low, Ph.D. principal investigator
Clinical Research Center, Malaysia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Clinical Research Centre, Malaysia at 8 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ee Vien Low, Ph.D. (+60333628829, evlow@moh.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and proportion of study participants with COVID-19 related Hospitalization (time frame: Within 28 days after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.