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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347915
• Other study ID #: BK-CLV-201
• Status: Completed
• Phase: Phase 2
• Start date: May 26, 2020
• Est. completion date: February 26, 2021

Study information

• Verified date: July 2022
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 26, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

5. 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Clevudine
Clevudine 120mg once a day for 14 days (up to 21 days)
• Placebo
Matching Placebo once a day for 14 days (up to 21 days)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)	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.	within 15days
Secondary	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
Secondary	The rate of subjects indicated by the improvement of lung invasive		within Day 29 (or EOT)
Secondary	The change of viral load		Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline