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Cancelled by the investigator Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy in the treatment of novel coronavirus pneumonia (COVID-19)

Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030417
Enrollment
Unknown
Registered
2020-03-01
Start date
2020-03-01
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

Experimental group:Combined standard therapy of chloroquine phosphate aerosol inhalation solution
control group:Water for injection atomization inhalation combined with standard therapy

Sponsors

Harbin infectious diseases hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old, both male and female; 2. The eligible subjects (male and female) with fertility must agree to take effective contraceptive measures from the beginning of self-sufficiency with their partners to 6 months after drug withdrawal; 3. Novel coronavirus pneumonia diagnosis novel coronavirus pneumonia novel coronavirus pneumonia diagnosis and treatment plan (latest edition) is confirmed; 4. Drugs without chloroquine and its derivatives within three months; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with allergic history to 4-aminoquinoline (such as chloroquine, hydroxychloroquine, piperaquine, aminophenquine, etc.) and similar drugs (such as primaquine, etc.) were identified; 2. Patients with blood system diseases; 3. Patients with hearing impairment; 4. Patients with known severe liver disease, basic disease of liver cirrhosis or ALT / AST increased more than 2 times of the upper limit of normal; 5. Patients who drink alcohol or are taking hepatotoxic drugs; 6. Patients with known impairment of renal function (estimated glomerular filtration rate [EGFR] =450ms; 10. Patients with uncorrected hypokalemia and hypomagnesemia; 11. Patients with known retinopathy, fundus disease and macular disease; 12. Patients known to have mental illness; 13. Patients with pancreatitis; 14. Female patients in pregnancy, childbearing age with positive pregnancy test or lactation; 15. Taking drugs that affect drug absorption, metabolism and excretion, can prolong QTc interval, can affect drug efficacy or increase adverse reactions; 16. Patients with a history of malignancy in the last 5 years; 17. Patients with skin diseases (including skin rash, dermatitis, psoriasis); 18. The novel coronavirus pneumonia diagnosis and treatment scheme (latest edition) has been adopted in the standard treatment of 2 and 2 or more antiviral drugs; 19. The researchers judged that it was not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Temperature returns to normal for more than 3 days;Respiratory symptoms improved significantly;Pulmonary imaging showed that acute exudative lesions were significantly improved;Negative for two consecutive tests of respiratory pathogenic nucleic acid (sampling interval at least 1 day);

Secondary

MeasureTime frame
Proportion of severe cases;Length of stay;Oxygen saturation;Mechanical ventilation time;

Countries

China

Contacts

Public ContactJing Xu

Harbin Peiyou Jiandi Biotechnology Co., Ltd

18604501911@163.com+86 18604501911

Outcome results

None listed

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