Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06223932
Eligibility Criteria:
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06223932
Study Brief:
Protocol Section:
NCT06223932