Status:
UNKNOWN
A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19.
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. A study found that the increase in hyaluronic acid levels is closely related to the...
Eligibility Criteria
Inclusion
- Participants who have a positive SARS-CoV-2 test result ;
- Participants who have been diagnosed with mild or ordinary type of COVID-19 infection;
- Participants whose serum hyaluronic acid level was higher than the upper limit of normal value;
- Participants who must agree to adhere to contraception restrictions;
- Participants who understand and agree to comply with planned study procedures;
- Participants who give signed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
- Participants who have any of the following conditions when screening:
- ALT or AST \> 5 ULN;
- Scr \> 1.5 ULN or Ccr \< 50 mL/min;
- TBIL \> 2ULN ;
- HGB ≤ 90 g/ L;
- PLT ≤ 75×10\^9/ L;
- Participants who have suspected/active infections during the screening period including uncontrolled active bacterial, viral or fungal infections that require systemic treatment, except COVID-19 virus infections;
- Participants who have any active autoimmune diseases during the screening period and need to be treated with immunosuppressants, including biological agents;
- Participants who have a medical history of organ transplantation, or plan for organ transplantation including liver transplantation;
- Participants who need a loading dose of anti-platelet drugs, such as aspirin (\>300 mg/day) and clopidogrel (\>300 mg/day);
- Participants who have a medical history of central nervous system and digestive system bleeding, or a tendency of gastrointestinal bleeding, local active ulcer lesions included, in the last three months;
- Participants who have biliary obstruction;
- Female participants who are pregnant or breast-feeding or plan to be pregnant within this study period;
- Male participants whose wife or partner plan to be pregnant within this study period.
- Participants who have taken the drugs containing coumarin compounds, such as warfarin, within 3 days before screening;
- Participants who have other diseases requiring hospitalization and/or in a need of surgical treatment within 7 days before screening, or have suffered from life-threatening diseases within 30 days before screening;
- Participants who have known allergies to any of the components used in the formulation of the interventions;
- Participants who have taken a part in a clinical study of an investigational intervention in the last 28 days. After 5 half-lives or 28 days, whichever is longer, can be allowed for screening;
- Participants who are not suitable for this trial, and with any medical condition will compromise their own safety.
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2022
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT05386420
Start Date
May 23 2022
End Date
November 15 2022
Last Update
June 9 2022
Active Locations (1)
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1
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200030