Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19Patients. Turkey Cohort, Prospective, Observational, Comparative Study In the antiviraltreatment of COVID-19, molnupiravir, an RdRp (RNA-dependent RNA polymerase) inhibitor,was the first agent shown to reduce death and hospitalization in a reliable/adequatephase-3 clinical trial. For this reason, molnupiravir has been approved for emergency usein many countries, including Turkey, as it is still an unmet need in the treatment ofCOVID-19. However, it is not yet known which factors related to the patient or thedisease are important for this drug to be effective. In addition, since this is the firsttime 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 thevirus, there are some hypotheses that this effect may lead to the emergence of new andmore dangerous variants.
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.
Drug: Molnupiravir
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.
Inclusion Criteria:
1. 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
2. Positive SARS-CoV-2 PCR test or SARS-CoV-2 rapid antigen test in nasopharyngeal swab
specimen,
3. Have at least 1 symptom consistent with COVID-19,
4. No more than 5 days have elapsed since the onset of symptoms,
5. Outpatients or those diagnosed with COVID-19 while hospitalized for reasons other
than COVID-19,
6. Those for whom molnupiravir treatment is recommended in the current COVID-19
Treatment Guidelines of the Ministry of Health.
Exclusion Criteria:
1. <18 years old
2. Pregnant or breastfeeding
3. Patients whom the researcher thinks may have problems with compliance,
4. Patients with an increased need for oxygen due to COVID-19
5. Patients receiving corticosteroid or anti-cytokine therapy for COVID-19,
6. Patients >5 days from the onset of symptoms
7. Subjects with chronic diarrhea or chronic gastrointestinal problems that may impair
drug absorption,
8. History of allergy to molnupiravir,
9. Those with chronic alcoholism
10. Those who have received another antiviral therapy targeting SARS-CoV-2 (favipiravir,
remdesivir, specific monoclonal antibodies, etc.)
Istanbul University, Istanbul Faculty of Medicine, Department of Infectious Disease
Istanbul, Fatih, Turkey
Cerrahpasa Faculty of Medicine Infectious Disease Departament
Istanbul, Fatih, Turkey
Ankara City Hospital
Ankara, Turkey
Ankara University Faculty of Medicine
Ankara, Turkey
CAM and SAKURA Training and Research Hospital
Istanbul, Turkey
Istanbul Haseki Training and Research Hospital
Istanbul, Turkey
Koc University Hospital
Istanbul, Turkey
Umraniye Training and Research Hospital
Istanbul, Turkey
Not Provided