Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT06223932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients.
Sponsor:
Serap Yavuz
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients. Turkey Cohort, Prospective, Observational, Comparative Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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:
1. Molnupiravirin in COVID-19 patients,
1. Clinical improvement on days 3, 5, 10, 14 and 28 (according to the WHO clinical status assessment scale)
2. On oxygen requirement in the first 28 days,
3. On the need for ICU in the first 28 days,
4. On the need for ventilatory support in the first 28 days,
5. Viral clearance rates on days 3, 5, 10 and 14,
6. 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
7. On mortality rates at 28 days and 3 months
8. Adverse drug effects seen at 3rd, 5th, 10th, 14th days, 28 days, 3rd and 6th months, analysis of the effects
9. Monitoring the patient's general condition and new disease diagnoses at 3 and 6 months
2. 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
3. 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.
The secondary objectives of this study are as follows:
1. Molnupiravirin in COVID-19 patients,
1. Clinical improvement on days 3, 5, 10, 14 and 28 (according to the WHO clinical status assessment scale)
2. On oxygen requirement in the first 28 days,
3. On the need for ICU in the first 28 days,
4. On the need for ventilatory support in the first 28 days,
5. Viral clearance rates on days 3, 5, 10 and 14,
6. 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
7. On mortality rates at 28 days and 3 months
8. Adverse drug effects seen at 3rd, 5th, 10th, 14th days, 28 days, 3rd and 6th months, analysis of the effects
9. Monitoring the patient's general condition and new disease diagnoses at 3 and 6 months
2. 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
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: