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

• Register: ChiCTR
• Last refreshed on: 17 February 2020
• Main ID: ChiCTR2000029935
• Date of registration: 2020-02-16
• Prospective Registration: No
• Primary sponsor: HwaMei Hospital, University of Chinese Academy of Sciences
• Public title: A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)
• Scientific title: A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)
• Date of first enrolment: 2020-02-06
• Target sample size: Case series:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=49607
• Study type: Interventional study
• Study design: Single arm
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Ting Cai
• Affiliation: HwaMei Hospital, University of Chinese Academy of Sciences

• Name: Honghua Ye
• Affiliation: HwaMei Hospital, University of Chinese Academy of Sciences

Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Novel Coronavirus Pneumonia (COVID-19)

Intervention(s)

Case series:Treated with conventional treatment combined with Chloroquine Phosphate;

Primary Outcome(s)

Length of hospital stay;

Secondary Outcome(s)

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;

Source(s) of Monetary Support

HwaMei Key Research Fund (2020HMZD18)

Ethics review

Status: Approved
Approval date: 26/08/2013
Contact:

Yaoren Hu