Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection
NCT04374032 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2020-12-24
Summary
An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection
Conditions
- COVID-19 Infection
Interventions
- DRUG
-
metenkefalin + tridecactide
ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
- DRUG
-
The standard of care
The usual therapeutically established protocol, for the treatment of patients with moderate to severe COVID-19 infection prescribed by The Agency for medicinal products and medical devices of Bosnia and Herzegovina
Sponsors & Collaborators
-
Bosnalijek D.D
lead INDUSTRY
Principal Investigators
-
Rusmir Baljić, PhD · Clinical Center University of Sarajevo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-01
- Primary Completion
- 2020-10-07
- Completion
- 2020-11-03
Countries
- Bosnia and Herzegovina
Study Locations
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