NCT06383819

Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19

Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilisate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection

Detailed description

The main objective of the clinical study was to prove the superiority of the efficacy of the drug Longidaza® over placebo when used in adult patients with residual changes in the lungs after COVID-19 infection based on the dynamics of respiratory function

Conditions

• Post-Acute COVID-19 Syndrome
• Lung Disease With Polymyositis
• Fibrosis
• Lung Diseases, Interstitial
• Lung; Disease, Interstitial, With Fibrosis

Interventions

Type	Name	Description
DRUG	Longidaza®	dose 3000 IU intramuscularly once every 5 days, 15 injections
DRUG	Placebo	intramuscularly once every 5 days, 15 injections

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-04-25
• Last updated: 2025-06-03

Locations

30 sites across 1 country: Russia