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NCT07720596

Overview

NCT ID: NCT07720596
Lead Sponsor: Charles University, Czech RepublicOTHER
Official Title: Effect of Molnupiravir on COVID-19 Mortality in the Omicron Era: A Real-World Target Trial Emulation Using Complete Czech Nationwide Data
Brief Summary: This retrospective real-world target trial emulation uses complete Czech nationwide registry data to evaluate whether molnupiravir treatment is associated with lower COVID-19 mortality during the Omicron era. The study compares adults with confirmed acute COVID-19 treated with molnupiravir in addition to standard care versus matched controls treated with standard care without molnupiravir. Patients are followed for three months from time zero, and primary endpoints are the COVID-19 case fatality rate and all-cause mortality.
Conditions: COVID-19
SARS-CoV-2

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adult infection episodes among patients aged 20 years or older.

Confirmed acute SARS-CoV-2 positivity recorded in the Infectious Disease Information System (ISIN) during the Omicron-era study period.

Eligible for analysis at time zero, defined as the date of molnupiravir dispensing for treated patients and the matched date for controls.

Mild-to-moderate COVID-19 suitable for oral antiviral treatment, operationalized by excluding those already dead, in ICU, or receiving mechanical ventilation at time zero.

Exclusion Criteria:

Age below 20 years at time of positivity.

Death, ICU hospitalization, or mechanical ventilation at time zero.

Receipt of molnupiravir, monoclonal antibodies, remdesivir, or nirmatrelvir/ritonavir within 14 days before positivity.

Receipt of molnupiravir, monoclonal antibodies, remdesivir, or nirmatrelvir/ritonavir within 14 days after the qualifying SARS-CoV-2 positivity, but outside the treatment-initiation eligibility window according to the SmPC.

Central Contacts: No data available
Locations: Department of Pharmacology, Third Faculty of Medicine, Charles University