The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Clevudine

• Registration Number: NCT04347915
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Study Start: 2020-05-26
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Over 19 years of age

2. COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment

3. Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening

4. Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening:

   [armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.)

5. Patients with evidence of lung invasions as a result of radiation tests

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Exclusion Criteria

1. Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
2. Patients who participated in other clinical trials related to COVID-19.
3. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)
Clevudine	Clevudine	Clevudine 120mg (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)

Primary Outcome Measures

Name	Time	Method
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)	within 15days	The primary efficacy endpoint for this clinical trial is the rate of patients with negative SARS-Coronavirus-2 (SARS-CoV-2) in a two-day continuous Real-Time-RT-PCR test from baseline to before the 15th day.

Secondary Outcome Measures

Name	Time	Method
The rate of subjects indicated by the improvement of lung invasive	within Day 29 (or EOT)
The change of viral load	Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests	Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of