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A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)

A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029935
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-02-06
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

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Case series:Treated with conventional treatment combined with Chloroquine Phosphate

Sponsors

HwaMei Hospital, University of Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission. Criteria for diagnosis (meet all the following criteria): 1. Epidemiologic history. 2. Clinical manifestations (meet any 2 of the following): fever, normal or decreased white blood cell count or lymphopenia in the early stage of onset, and Chest radiology in the early stage shows multiple small patchy shadowing and interstitial changes which is especially significant in periphery pulmonary. Furthermore, it develops into bilateral multiple ground-glass opacity and infiltrating shadowing. Pulmonary consolidation occurs in severe cases. Pleural effusion is rare; 3. Confirmed case (suspected case obtained one of the following etiologic evidences): a positive result to real-time reverse-transcriptase PCR for respiratory specimen or blood specimen, or Genetic sequencing result of virus in respiratory or blood specimens are highly homologous to SARS-CoV-2.

Exclusion criteria

Exclusion criteria: 1. Female patients during pregnancy; 2. Patients with known allergy to chloroquine; 3. Patients with haematological diseases; 4. Patients with chronic liver or kidney diseases at the end stage; 5. Patients with arrhythmia and chronic heart disease; 6. Patients with retinal disease, hearing deficiency or hearing loss; 7. Patients with psychiatric diseases; 8. Patients taking digitalis due to underlying diseases.

Design outcomes

Primary

MeasureTime frame
Length of hospital stay;

Secondary

MeasureTime frame
Length from the day of admission to the day returning to normal body temperature, from admission to two consecutive negative results of respiratory pathogenic nucleic acid test (sampling interval of at least 1 day), and from admission to the chest CT shows significant improvement;The proportion of cases transformed from mild to severe illness.;30-day etiologic mortality;30-days all-cause mortality;Proportion of relapse within 14 days after discharge;C-reactive protein;Inflammatory factors;

Countries

China

Contacts

Public ContactTing Cai

HwaMei Hospital, University of Chinese Academy of Sciences

caiting@ucas.ac.cn+86 13738498188

Outcome results

None listed

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