Cancelled by the investigator A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in serious/critically ill patients with novel coronavirus pneumonia (COVID-19)

A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in serious/critically ill patients with novel coronavirus pneumonia (COVID-19)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029826

Enrollment

Unknown

Registered

2020-02-14

Start date

2020-02-17

Completion date

Unknown

Last updated

2020-03-16

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

Phosphoric chloroquine:2 tablets phosphoric chloroquine BID, complicated with therapy recommended by "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5)"

Placebo:2 tablets placebo BID

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the requirements of the New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5); 2. Aged 18-75 years male or female; 3. Serious patient meet one of the following: (1) respiratory distress wiht respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen(PaO2)/oxygen concentration<=300mmHg; 4. critically ill patients meet one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU; 5. Agree to particapate this study and write the informed consent.

Exclusion criteria

Exclusion criteria: If subject meet one of the following exclusion critera, he/she cannot be enrolled in this study: 1. Be dysphagia and cannot receive drud by oral administration; 2. Complicated with pneumonia infected by other virus; 3. Allergy to or intolerance to study drug phosphoric chloroquine; 4. With significantly abnormal liver function( judged per local Laboratory reference range): -ALT/AST>5 times ULN or; -ALT/AST>3 times ULN, and total bilirubin>2 times ULN or; -need dDialysis treatment, or GFR=30 mL/min/1.73 m2. 5. With definate history of cadiac diease and arrhythmia and QT prolong; 6. Need to receive digitalis for original diease; 7. With history of grug abuse and drug dependency; 8. Pregant or lactating women; 9. One that the investigator consider not applicable for this study.

Design outcomes

Primary

Measure	Time frame
Mortality rate;	—

Secondary

Measure	Time frame
Time of improvement of clinical symptoms;Remission time of fever;Duration of mechanical ventilation;Hospitalization time;Proportion of virus positive patients;Improvement of chest imaging;Incidence of related complications;	—

Countries

China

Contacts

Public ContactJinghua Mao

Jingzhou Central Hospital

hbjzyyywlc@163.com+86 071 68497225

Outcome results

None listed

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