A multicenter, single-blind, randomized controlled clinical trial for chloroquine phosphate in the treatment of novel coronavirus pneumonia (COVID-19)

A multicenter, single-blind, randomized controlled clinical trial for chloroquine phosphate in the treatment of 2019 novel coronavirus-infected pneumonia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031204

Enrollment

Unknown

Registered

2020-03-24

Start date

2020-01-30

Completion date

Unknown

Last updated

2020-03-30

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

Experimental treatment group:Oral chloroquine phosphate tablets (treatment group)

control group:Oral placebo group (control group)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. male and female aged 18-70 years; 2. positive result of test for 2019 novel coronavirus nucleic acid; 3. Clinical diagnosed with pneumonia; 4. onset within 7 days (severe cases can be delayed to 14 days); 5. the informed consent shall be signed by me or the authorized agent; 6. subjects who can take oral medication or who receive oral medication; 7. agree to collect clinical samples; 8. female subjects of child-bearing age are not pregnant and agree to take effective contraceptive measures within 7 days of the last oral medication to ensure that they are not pregnant; 9. men agree not to have sex with women for seven days after their last oral medication.

Exclusion criteria

Exclusion criteria: 1. severe vomiting and difficulty in taking oral medication or in taking oral medication; 2. pregnant and nursing women; 3. subjects received lopinavir/ridonavir, ribavirin, monoclonal antibodies and other specific antiviral drugs in the week prior to admission; 4. cases of respiratory failure requiring mechanical ventilation; 5. cases of shock; 6. combined with other organ failure requires intensive care unit; 7. patients with no clinical expectation of survival and only end-of-life care, or those in a deep coma who did not respond to supportive treatment within three hours of admission.

Design outcomes

Primary

Measure	Time frame
Clearance time of virus RNA;	—

Secondary

Measure	Time frame
Rate of progression to severe case;Duration of fever;Diagnosis value of C-reactive protein;Absolute value and percentage of peripheral blood lymphocytes;Lung image features improving time;	—

Countries

China

Contacts

Public ContactJin Ronghua

Beijing You'an Hospital, Capital Medical University

jin_eagle@sina.com+86 13901374552

Outcome results

None listed

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