Skip to content

Efficacy of Chloroquine and Lopinavir/ Ritonavir in mild/general novel coronavirus (CoVID-19) infections: a prospective, open-label, multicenter randomized controlled clinical study

Efficacy of Chloroquine and Lopinavir/ Ritonavir in mild/general novel coronavirus (CoVID-19) infections: a prospective, open-label, multicenter randomized controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029741
Enrollment
Unknown
Registered
2020-02-11
Start date
2020-02-12
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

2019 Novel Coronavirus Infection (CoVID-19)

Interventions

control group:Lopinavir / Ritonavir

Sponsors

The Fifth Affiliated Hospital Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (All the following criteria are met before being selected): 1. Aged >= 18 years; 2. Meet all the following criteria (refer to confirmed cases in the 5th edition of the diagnosis and treatment plan): (1) Epidemiological history; (2) Clinical manifestations (according to any of the following 2): fever; normal or decreased white blood cell count or reduced lymphocyte count in the early stages of onset; multiple small patchy shadows and interstitial changes in early chest imaging, which are evident in the extrapulmonary zone. Furthermore, it develops multiple ground glass infiltration and infiltrates in both lungs. In severe cases, pulmonary consolidation and pleural effusion are rare. (3) Confirmed: Suspected cases have one of the following pathogenic evidence: respiratory specimens, blood specimens, or fecal specimens are detected by real-time fluorescent RT-PCR to detect novel coronavirus nucleic acid; the above-mentioned specimens are genetically sequenced and highly homologous to known new coronaviruses . (4) Light or ordinary patients; (5) With or without anti-viral drugs other than chloroquine phosphate, lopinavir/ritonavir.

Exclusion criteria

Exclusion criteria: (Subjects cannot enter the study if they meet any of the following conditions): 1. Patients with a history of allergy to chloroquine phosphate, lopinavir, and ritonavir; 2. Patients with hematological diseases; 3. Patients with chronic liver and kidney disease and reaching the end stage; 4. Patients with arrhythmia and chronic heart disease; 5. Patients known to have retinal disease, hearing loss or hearing loss; 6. Patients with known mental illness; 7. Patients who must use digitalis because of the original underlying disease; 8. Pancreatitis; 9. Hemophilia; 10. Broad bean disease; 11. Female patients during pregnancy.

Design outcomes

Primary

MeasureTime frame
Length of stay;Length of severe;oxygenation index during treatment;all-cause mortality in 28 days;Peripheral blood cell count (including white blood cells, lymphocytes, neutrophils, etc.);procalcitonin;C-reactive protein;Inflammatory factors (including IL-6, IL-10, TNF-a, etc.);Lymphocyte subsets and complement;Coagulation indicators (prothrombin time, activated partial prothrombin time, fibrinogen, D-dimer, platelet count);Virus nucleic acid;

Secondary

MeasureTime frame
Others (liver and kidney function, muscle enzymes, myoglobin);

Countries

China

Contacts

Public ContactXia Jinyu

The Fifth Affiliated Hospital Sun Yat-Sen University

xiajinyu@mail.sysu.edu.cn+86 13823078064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026