drugset / Trial / NCT05516550

Study to Assess Efficacy and Safety of Treamid for Patients With Reduced Exercise Tolerance After COVID-19

NCT05516550 ↗

Phase 2/3 Unknown 412 enrolled PHARMENTERPRISES LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The innovative drug Treamid is planned for use in the treatment of patients with persistent lung damage and reduced exercise tolerance exertion after COVID-19 pneumonia in a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical study to assess the efficacy and safety of Treamid during a 28-day treatment. The primary objective of the study is to prove that in the Treamid group, the proportion of patients achieving clinically significant load tolerance is statistically significantly higher than in the placebo group. The secondary objective of the study is to evaluate the safety of Treamid and achievement of clinically significant improvements in indicators for various questionnaires and spirometry data.

Timeline

Start
2022-08
Primary completion
2022-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Treamid Small molecule 25 mg —
Subject Treamid Small molecule 50 mg —