COVID-19NCT06223932
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients.
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Serap Yavuz at 8 sites in Turkey (Türkiye).
Trial summary
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study In the antiviral treatment of COVID-19, molnupiravir, an RdRp (RNA-dependent RNA polymerase) inhibitor, was the first agent shown to reduce death and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- Molnupiravir
- How many people
- 2,600 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- 7 Jul 2022to Feb 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 18-65 years old patients * Patients with a confirmed diagnosis of COVID-19 who were offered and accepted molnupiravir treatment by their attending physician: 1300 patients * Patients with a confirmed diagnosis of COVID-19 who were offered molnupiravir treatment by the attending physician and refused to take it: 1300 patients
Who may be able to join
- Obesity (BMI >30 kg/m2 in adults), chronic renal failure, diabetes mellitus, presence of immunosuppressive diseases or drug use, cardiovascular diseases (including congenital heart diseases or hypertension), chronic lung diseases, among the comorbidities that cause severe Covid-19; (e.g. COPD, moderate to severe asthma, cystic fibrosis, interstitial lung disease, pulmonary hypertension, chronic liver disease concomitant to nonconcomitant cirrhosis), neurological developmental diseases (e.g. cerebral palsy), sickle cell anemia, other medical complex conditions (e.g. genetic or metabolic syndromes or severe congenital anomalies) and
- Positive SARS-CoV-2 PCR test or SARS-CoV-2 rapid antigen test in nasopharyngeal swab specimen,
- Have at least 1 symptom consistent with COVID-19,
- No more than 5 days have elapsed since the onset of symptoms,
- Outpatients or those diagnosed with COVID-19 while hospitalized for reasons other than COVID-19,
- Those for whom molnupiravir treatment is recommended in the current COVID-19 Treatment Guidelines of the Ministry of Health.
Who cannot join
- <18 years old
- Pregnant or breastfeeding
- Patients whom the researcher thinks may have problems with compliance,
- Patients with an increased need for oxygen due to COVID-19
- Patients receiving corticosteroid or anti-cytokine therapy for COVID-19,
- Patients >5 days from the onset of symptoms
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- Subjects with chronic diarrhea or chronic gastrointestinal problems that may impair drug absorption,
- History of allergy to molnupiravir,
- Those with chronic alcoholism
- Those who have received another antiviral therapy targeting SARS-CoV-2 (favipiravir, remdesivir, specific monoclonal antibodies, etc.)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites
Ankara City Hospital
Ankara
Ankara University Faculty of Medicine
Ankara
Istanbul University, Istanbul Faculty of Medicine, Department of Infectious Disease
Istanbul, Fatih, 34093
Cerrahpasa Faculty of Medicine Infectious Disease Departament
Istanbul, Fatih
CAM and SAKURA Training and Research Hospital
Istanbul
Istanbul Haseki Training and Research Hospital
Istanbul
Koc University Hospital
Istanbul
Umraniye Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study In the antiviral treatment of COVID-19, molnupiravir, an RdRp (RNA-dependent RNA polymerase) inhibitor, was the first agent shown to reduce death and hospitalization in a reliable/adequate phase-3 clinical trial. For this reason, molnupiravir has been approved for emergency use in many countries, including Turkey, as it is still an unmet need in the treatment of COVID-19. However, it is not yet known which factors related to the patient or the disease are important for this drug to be effective. In addition, since this is the first time it will be widely used, rare or long-term adverse effects have not been identified. Since molnupiravirin is known to exert antiviral activity by inducing mutations in the virus, there are some hypotheses that this effect may lead to the emergence of new and more dangerous variants.
Read the detailed description
The primary objective of this study is to determine whether molnupiravir, which will be used as the first antiviral drug outside of the repositioned options in the treatment of COVID-19, is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life. (Note: In patients diagnosed with COVID-19 while hospitalized for other reasons and included in the study, COVID-19-related oxygen requirement + COVID-19-related death will be considered as the primary outcome).
The secondary objectives of this study are as follows:
- Molnupiravirin in COVID-19 patients,
- Clinical improvement on days 3, 5, 10, 14 and 28 (according to the WHO clinical status assessment scale)
- On oxygen requirement in the first 28 days,
- On the need for ICU in the first 28 days,
- On the need for ventilatory support in the first 28 days,
- Viral clearance rates on days 3, 5, 10 and 14,
- On day 10, on serum glucose, BUN, creatinine, AST, ALT, CRP, LDH, procalcitonin, D-Dimer levels, blood leukocyte, neutrophil and lymphocyte, erythrocyte and platelet counts
- On mortality rates at 28 days and 3 months
- Adverse drug effects seen at 3rd, 5th, 10th, 14th days, 28 days, 3rd and 6th months, analysis of the effects
- Monitoring the patient's general condition and new disease diagnoses at 3 and 6 months
- In COVID-19 patients receiving molnupiravir, 10) Identification of the presence and proportion of mutant SARS-CoV-2 present in day 5, 10 and 14 samples 11) Determination of the ratio of those who grow in viral culture and those who may be infectious in people whose SARS-CoV-2 positivity was detected in samples on the 5th, 10th and 14th days 12) Determination of the phenotypic susceptibility of SARS-CoV-2 strains to molnupiravir in samples collected on days 5, 10 and 14
- Determining which factors are associated with the efficacy of molnupiravir in reducing hospitalization and mortalitySince it is known that molnupiravir has antiviral activity by inducing mutation in the virus, there are some hypotheses that this effect may lead to the emergence of new and more dangerous variants.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- Molnupiravir
- Keywords
- COVID-19, SARS-CoV-2 Infection, Molnupiravir, 11881, Istanbul University, Department of Infectious Disease
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolnupiravirDrug
COVID-19 diagnosed patients receiving molnupiravir will be evaluated to show if Molnupiravir is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 diagnosed patients receiving molnupiravir | COVID-19 diagnosed patients receiving molnupiravir treatment Receives: Drug: Molnupiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molnupiravir effectineness in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life
The primary objective of this study is to determine whether molnupiravir, which will be used as the first antiviral drug outside of the repositioned options in the treatment of COVID-19, is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life. (Note: In patients diagnosed with COVID-19 while hospitalized for other reasons and included in the study, COVID-19-related oxygen requirement + COVID-19-related death will be considered as the primary outcome).
Measured: 28 Days, 3 month and 6 month follow-up after diagnose and treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start7 Jul 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (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
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serap Yavuz
- Sponsor type
- University, hospital or other
- Collaborators
- MDX Klinik Araştırma Egitim ve Danismanlik Ltd. Sti.
- Responsible party
- Sponsor-investigator, Serap Yavuz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223932
- Sponsor's protocol ID
- 11881
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study
- ClinicalTrials.gov ID
- NCT06223932
- Acronym / sponsor ID
- 11881
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2 Infection, Molnupiravir, 11881, Istanbul University, Department of Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Serap YavuzUniversity, hospital or other
- Collaborators
- MDX Klinik Araştırma Egitim ve Danismanlik Ltd. Sti.
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study In the antiviral treatment of COVID-19, molnupiravir, an RdRp (RNA-dependent RNA polymerase) inhibitor, was the first agent shown to reduce death and hospitalization in a reliable/adequate phase-3 clinical trial. For this reason, molnupiravir has been approved for emergency use in many countries, including Turkey, as it is still an unmet need in the treatment of COVID-19. However, it is not yet known which factors related to the patient or the disease are important for this drug to be effective. In addition, since this is the first time it will be widely used, rare or long-term adverse effects have not been identified. Since molnupiravirin is known to exert antiviral activity by inducing mutations in the virus, there are some hypotheses that this effect may lead to the emergence of new and more dangerous variants.
Detailed description
The primary objective of this study is to determine whether molnupiravir, which will be used as the first antiviral drug outside of the repositioned options in the treatment of COVID-19, is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life. (Note: In patients diagnosed with COVID-19 while hospitalized for other reasons and included in the study, COVID-19-related oxygen requirement + COVID-19-related death will be considered as the primary outcome).
The secondary objectives of this study are as follows:
- Molnupiravirin in COVID-19 patients,
- Clinical improvement on days 3, 5, 10, 14 and 28 (according to the WHO clinical status assessment scale)
- On oxygen requirement in the first 28 days,
- On the need for ICU in the first 28 days,
- On the need for ventilatory support in the first 28 days,
- Viral clearance rates on days 3, 5, 10 and 14,
- On day 10, on serum glucose, BUN, creatinine, AST, ALT, CRP, LDH, procalcitonin, D-Dimer levels, blood leukocyte, neutrophil and lymphocyte, erythrocyte and platelet counts
- On mortality rates at 28 days and 3 months
- Adverse drug effects seen at 3rd, 5th, 10th, 14th days, 28 days, 3rd and 6th months, analysis of the effects
- Monitoring the patient's general condition and new disease diagnoses at 3 and 6 months
- In COVID-19 patients receiving molnupiravir, 10) Identification of the presence and proportion of mutant SARS-CoV-2 present in day 5, 10 and 14 samples 11) Determination of the ratio of those who grow in viral culture and those who may be infectious in people whose SARS-CoV-2 positivity was detected in samples on the 5th, 10th and 14th days 12) Determination of the phenotypic susceptibility of SARS-CoV-2 strains to molnupiravir in samples collected on days 5, 10 and 14
- Determining which factors are associated with the efficacy of molnupiravir in reducing hospitalization and mortalitySince it is known that molnupiravir has antiviral activity by inducing mutation in the virus, there are some hypotheses that this effect may lead to the emergence of new and more dangerous variants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 diagnosed patients receiving molnupiravir | – | Drug: MolnupiravirCOVID-19 diagnosed patients receiving molnupiravir treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 18-65 years old patients * Patients with a confirmed diagnosis of COVID-19 who were offered and accepted molnupiravir treatment by their attending physician: 1300 patients * Patients with a confirmed diagnosis of COVID-19 who were offered molnupiravir treatment by the attending physician and refused to take it: 1300 patients
Key inclusion criteria (6 listed)
- Obesity (BMI >30 kg/m2 in adults), chronic renal failure, diabetes mellitus, presence of immunosuppressive diseases or drug use, cardiovascular diseases (including congenital heart diseases or hypertension), chronic lung diseases, among the comorbidities that cause severe Covid-19; (e.g. COPD, moderate to severe asthma, cystic fibrosis, interstitial lung disease, pulmonary hypertension, chronic liver disease concomitant to nonconcomitant cirrhosis), neurological developmental diseases (e.g. cerebral palsy), sickle cell anemia, other medical complex conditions (e.g. genetic or metabolic syndromes or severe congenital anomalies) and
- Positive SARS-CoV-2 PCR test or SARS-CoV-2 rapid antigen test in nasopharyngeal swab specimen,
- Have at least 1 symptom consistent with COVID-19,
- No more than 5 days have elapsed since the onset of symptoms,
- Outpatients or those diagnosed with COVID-19 while hospitalized for reasons other than COVID-19,
Key exclusion criteria (10 listed)
- <18 years old
- Pregnant or breastfeeding
- Patients whom the researcher thinks may have problems with compliance,
- Patients with an increased need for oxygen due to COVID-19
- Patients receiving corticosteroid or anti-cytokine therapy for COVID-19,
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 |
|---|---|---|
| MolnupiravirCOVID-19 diagnosed patients receiving molnupiravir will be evaluated to show if Molnupiravir is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life. | Drug | COVID-19 diagnosed patients receiving molnupiravir |
Primary outcome
Molnupiravir effectineness in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life
Time frame: 28 Days, 3 month and 6 month follow-up after diagnose and treatment
The primary objective of this study is to determine whether molnupiravir, which will be used as the first antiviral drug outside of the repositioned options in the treatment of COVID-19, is effective in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life. (Note: In patients diagnosed with COVID-19 while hospitalized for other reasons and included in the study, COVID-19-related oxygen requirement + COVID-19-related death will be considered as the primary outcome).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and SARS-CoV-2 Infection, run by Serap Yavuz at 8 sites in Turkey (Türkiye).
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 6 inclusion and 10 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 25 Jan 2024. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molnupiravir effectineness in reducing the combined outcome of hospitalization/death due to COVID-19 in the first 28 days when used in real life (time frame: 28 Days, 3 month and 6 month follow-up after diagnose and treatment). 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 25 Jan 2024.