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A single center, prospective, randomized controlled study of paxlovid compared to Lianhua Qingwen in shortening the negative time of novel coronavirus positive patients

A single center, prospective, randomized controlled study of paxlovid compared to Lianhua Qingwen in shortening the negative time of novel coronavirus positive patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059739
Enrollment
Unknown
Registered
2022-05-10
Start date
2022-05-08
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease

Interventions

experimental group:Two namatvir tablets (pink, 150 mg each) combined with one ritonavir tablet (white, 100 mg each) were taken orally every 12 hours for 5 consecutive days.
control group:Lianhua Qingwen granule 6g/bag, take it with warm water after meals. Three times a day, one bag each time. Lianhua Qingwen Capsule 0.35g, orally, after meals, four capsules each time, th

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent in writing before the start of any research-specific operation or treatment, aged 18-90 years old, gender is not limited; 2. The patient is infected with the novel coronavirus and confirmed by rtPCR; 3. The nucleic acid has not turned negative 8 days after the initial treatment; 4. Eastern Cooperative Oncology Group (ECOG) activity status score of 0 or 1; 5. Sufficient baseline organ function and hematological function as determined by screening examination; 6. Must agree and be able to comply with the research visit plan and other requirements stipulated in the protocol, including telephone follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women with ECOG score greater than or equal to 2; 2. There are untreated tumor central nervous system (CNS) metastases. If at least 4 weeks after the end of the treatment of CNS metastasis, the subjects who have no new metastasis or progression of metastasis are allowed to enter this study. The CNS imaging examination during the screening period is not mandatory, and only those with clinical indications need to do it; 3. Those who have undergone major surgery within 28 days before randomization in this study; 4. Has uncontrolled active bleeding or bleeding tendency; 5. Clinically significant gastrointestinal abnormalities, which may affect the absorption of the study drug or even increase the risk of bleeding or perforation, any previous history of gastrointestinal perforation; 6. Suffering from other malignant tumors requiring treatment in the past 3 years; 7. Poorly controlled hypertension, defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg. Antihypertensive drugs allowed and rescreened; 8. Any one or more of the following medical history within 6 months before randomization: symptomatic peripheral vascular disease; coronary artery bypass surgery; myocardial infarction or unstable angina; cardiac angioplasty or stent implantation; Cerebrovascular accident, including transient ischemic attack; 9. New York Heart Association class III or IV congestive heart failure; 10. There are uncontrolled concurrent diseases, and these factors will affect the subject's compliance with the relevant requirements of this study; 11. There are the following incompatibility: (1) a1 receptor blocker: alfuzosin; (2) Analgesics: pethidine, piroxicam, propoxyphene; (3) Anti-anginal drugs: ranolazine; (4) Anticancer drugs: Neratinib, Venetoclax; (5) Antiarrhythmic drugs: amiodarone, bepridil, quinidine, propafenone, flecainide; (6) Antibiotics: fusidic acid; (7) Antifungal drug: voriconazole; (8) Antihistamines: astemizole, terfenadine; (9) Anti-gout drug: colchicine; (10) Antimycobacterial drug: rifabutin; (11) Antipsychotics/psycholeptics: lurasidone, clozapine; (12) Ergot derivatives: ergotamine, ergonovine; (13) Gastrointestinal motility drug: cisapride; (14) Blood lipid regulator HMG-CoA reductase inhibitors: lovastatin, simvastatin; (15) PDE5 inhibitors: avanafil, sildenafil, vardenafil; (16) Sedative/hypnotics: diazepam, diazepam, and oral midazolam.

Design outcomes

Primary

MeasureTime frame
Nucleic acid negative conversion time and negative conversion rate;

Countries

China

Contacts

Public ContactJunhua Zheng

Renji Hospital, Shanghai Jiaotong University School of Medicine

zhengjh0471@sina.com+86 13901722408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026