Hidroxicloroquine and cloroquine safety profile in patients with SARS-COV-2 infection (COVID-19) (SEHISACoV-2)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40461
• EU PAS number:
  EUPAS35528
• Study ID:
  40461
• Official title and acronym:
  Hidroxicloroquine and cloroquine safety profile in patients with SARS-COV-2 infection (COVID-19) (SEHISACoV-2)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Hydroxychloroquine and chloroquine are used to treat patients with COVID19 infection. However, several trials are ongoing and there is a lack of evidence related to the efficacy yet. For years, hydroxychloroquine and chloroquine have been used to treat malaria and they are considered clinically safe. Their adverse reactions usually are mild and transitory, but both have been associated with potentially lethal cardiovascular disorders. The safety profile in patients treated with other drugs for COVID19 infection and with other comorbidities or risk factors are worst known. The primary objective is to determine the frequency of cardiovascular disorders in patients with COVID19 infection treated with CQ/HCQ and with previous risk factors. The main study variables are QT segment length (difference before-after treatment), other ECG alterations, serious adverse events as defined by ICH and grade 3/4 adverse events as classified by CTCAE v.5.
• Study status:
  Planned

Research institution and networks

Institutions

Parc de Salut Mar Barcelona (PSMAR)

Spain

Study timelines

Date when funding contract was signed

Planned: 27/04/2020

Study start date

Planned: 01/04/2020

Data analysis start date

Planned: 22/04/2020

Date of interim report, if expected

Planned: 30/06/2020

Date of final study report

Planned: 30/04/2021

Sources of funding

Other

More details on funding

Own Funds

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable