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

NCT05516550 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Treamid

Participants will receive Treamid 25 mg once a day daily during 4 weeks

DRUG

Treamid twice a day

Participants will receive Treamid 25 mg in the morning and in the evening daily during 4 weeks

DRUG

Treamid once a day

Participants will receive Treamid 50 mg in the morning daily during 4 weeks

DRUG

Placebo

Participants will receive Placebo in the morning and in the evening daily during 4 weeks

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516550 on ClinicalTrials.gov