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Yiqing oral liquid in the treatment of novel coronavirus infection randomized controlled clinical studies

Phase 1
Conditions
ovel coronavirus Pneumonia (COVID-19)
Registration Number
ITMCTR2200005961
Lead Sponsor
Huashan Hospital Affiliated to Fudan University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) The Ct value of both N gene and ORF gene in the nucleic acid detection of novel coronavirus infection is less than 30 (fluorescence quantitative PCR method, the limit value is 40);
(2) Age 18-85 years old;
(3) The clinical classification belongs to light, common and heavy;
(4) More than 1 high-risk factor for progression to severe/critical illness;
(5) Voluntarily sign a written informed consent.

Exclusion Criteria

(1) Pregnant and lactating women;
(2) Those with allergic constitution (referring to those allergic to the above drugs or foods or to the known ingredients of the drug in this trial);
(3) mentally ill, or incapable of self-awareness;
(4) Patients taking other antiviral drugs (including proprietary Chinese medicines);
(5) Mechanical ventilation is being used or is expected to be urgently needed;
(6) Patients with severe acute heart, brain, kidney, digestive tract and other diseases (such as acute heart failure, acute myocardial infarction, acute cerebrovascular disease, renal failure requiring dialysis treatment, acute gastrointestinal bleeding, etc.), ALT, AST more than 3 times the upper limit of normal;
(7) Suspected or confirmed severe active bacterial, fungal, tuberculosis or other infections (except for COVID-19);
(8) Those who have other circumstances that the investigator considers unsuitable to participate in clinical trials.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The standard rate of N gene and ORF gene Ct value in the detection of new coronavirus nucleic acid;7-day clinical symptom score;
Secondary Outcome Measures
NameTimeMethod
Time for the first nucleic acid to turn negative;Disease exacerbation rate;
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