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Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

S

Shanghai Public Health Clinical Center

Status and phase

Completed
Phase 3

Conditions

COVID-19
Pneumonia, Pneumocystis
Coronavirus

Treatments

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT04261517
HC-COVID-19

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Hydroxychloroquine and conventional treatments
Experimental group
Description:
After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.
Treatment:
Drug: Hydroxychloroquine
Conventional treatments
No Intervention group
Description:
After randomization, subjects take conventional treatments without hydroxychloroquine.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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