Evaluation of the Efficacy and Safety of Molnupiravir Treatment in Mild/Moderate Covid-19 Patients.

NCT06223932 | Unknown FDA Drug

• 1 other identifier: 11881
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Infection; Molnupiravir; 11881; Istanbul University, Department of Infectious Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  28 Days, 3 month and 6 month follow-up after diagnose and treatment

Study Arms (1)

COVID-19 diagnosed patients receiving molnupiravir

COVID-19 diagnosed patients receiving molnupiravir treatment

Drug: Molnupiravir

Interventions

Molnupiravir DRUG

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.

COVID-19 diagnosed patients receiving molnupiravir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• \<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
• 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.)

Sponsors & Collaborators

• Serap Yavuz: lead
• MDX Klinik Araştırma Egitim ve Danismanlik Ltd. Sti.: collaborator

Study Sites (8)

Istanbul University, Istanbul Faculty of Medicine, Department of Infectious Disease

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Cerrahpasa Faculty of Medicine Infectious Disease Departament

Istanbul, Fatih, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

CAM and SAKURA Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 25, 2024
• Study Start: July 7, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

TU (8)