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

• Sponsor: Bukwang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04347915
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Clevudine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19
• Actual Study Start Date: May 26, 2020
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Drug: Clevudine; Clevudine 120mg once a day for 14 days (up to 21 days)
Placebo Comparator: 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)	Drug: Placebo; Matching Placebo once a day for 14 days (up to 21 days)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. The rate of subjects indicated by the improvement of lung invasive [within Day 29 (or EOT)]

3. The change of viral load [Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key 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.)

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Bukwang Pharmaceutical

Investigators

• Principal Investigator: Woo-Joo Kim, M.D.,Ph.D., Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bukwang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04347915
• Other Study ID Numbers: BK-CLV-201
• First Posted: Apr 15, 2020
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bukwang Pharmaceutical: Coronavirus disease-19(COVID-19)
• Additional relevant MeSH terms: COVID-19; Clevudine

Study Results

No Results Posted as of Jul 22, 2022