A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate in patients with novel coronavirus pneumonia (COVID-19)

A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate in hospitalized patients with novel coronavirus pneumonia (COVID-19)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029609

Enrollment

Unknown

Registered

2020-02-06

Start date

2020-02-10

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

mild-moderate chloroquine group:oral chloroquine phosphate

mild-moderate Lopinavir/ritonavir group:oral Lopinavir/ritonavir

mild-moderate combination group:chloroquine phosphate plus Lopinavir/ritonavir

severe-chloroquine group :oral chloroquine phosphate

severe- Lopinavir/ritonavir group:oral Lopinavir/ritonavir

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients has been diagnosed with 2019-nCoV pneumonia according to the fifth version of 2019-nCoV pneumonia management guideline made by the national health commission of the People's Repulic of China. More details see: http://www.nhc.gov.cn/yzygj/s7653p/202002/3b09b894ac9b4204a79db5b8912d4440.shtml

Exclusion criteria

Exclusion criteria: 1. Pregnant woman patients; 2. Documented allergic history to any of chloroquine phosphate, ritonavir and lopinavir; 3. Documented history of hematological system diseases; 4. Documented history of chronic liver and kidney diseases; 5. Documented history of cardiac arrhythmia or chronic heart diseases; 6. Documented history of retina or hearing dysfunction; 7. Documented history of mental illnesses; 8. Use of digitalis due to the previous disease; 9. Onging pancreatitis; 10. Documented history of hemophilia; 11. Documented history of glucose-6 phosphate dehydrogenase (G-6-PD) deficiency.

Design outcomes

Primary

Measure	Time frame
virus nucleic acid negative-transforming time;	—

Secondary

Measure	Time frame
28-day all-cause mortality;total length of hospitalization;ICU admission ratio;length of ICU stay;	—

Countries

China

Contacts

Public ContactHong Shan

The Fifth Affiliated Hospital of Sun Yat-Sen University

shanhong@mail.sysu.edu.cn+86 0756 2528573

Outcome results

None listed

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