Clinical trial NCT04261517: Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Official title: Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Pneumocystis
Coronavirus
COVID-19
Keywords: Pneumonia
COVID-19
hydroxychloroquine
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.

Detailed description: There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.

Eligibility criteria: Inclusion Criteria:

* The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China;
* Participants aged over 18;
* Written the informed consent.

Exclusion Criteria:

* Hypersensitivity to chloroquine or hydroxychloroquine;
* Women during pregnancy;
* Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
* Participants with retinal disease, hearing loss;
* Participants with severe neurological and mental illness;
* Subjects were considered to be unable to complete the study, or not suitable for the study by researchers.

Exit criteria:

* Subjects asked to withdraw the study
* Subject will benefit if withdraw according to researchers' suggestions

Primary outcomes:
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
timeFrame: 3 days after randomization
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
timeFrame: 5 days after randomization
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
timeFrame: 7 days after randomization
measure: The mortality rate of subjects at weeks 2
timeFrame: 14 days after randomization
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 14 days after randomization
measure: The critical illness rate of subjects at weeks 2
timeFrame: 14 days after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
citation: Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.