COVID-19 - Brazilian Health Regulatory Agency (ANVISA) authorizes Dompé's REPAVID-19, a Phase 2 Clinical Trial for Treatment of Severe Patients

COVID-19 - Brazilian Health Regulatory Agency (ANVISA) authorizes Dompé's REPAVID-19, a Phase 2 Clinical Trial for Treatment of Severe Patients

PR Newswire

MILAN, Sept. 2, 2020

10 Brazilian centers in São Paulo, Brasilia, Presidente Prudente, Sao José do Rio Preto, Varginha, Salvador de Bahia, Criciùma

The Phase 3 clinical study will be enlarged to the US

MILAN, Sept. 2, 2020 /PRNewswire/ -- Brazil's Health Regulatory Agency, ANVISA, has greenlighted Dompé's REPAVID-19, Clinical Trial of Reparixin for Treatment of Severe Covid-19 Patients.

 

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Reparixin inhibits the action of interleukin 8 (IL-8), one of the inflammatory signaling proteins that is thought to be associated with the lung injury seen in patients with SARS-CoV2 infection. Consequently, this action is aimed to be useful in the treatment of COVID-19 pneumonia patients. The treatment is based on Reparixin oral tablets 1200 mg TID till 21 days, in case of confirmed improvement after 7 days.

REPAVID-19 will enroll 48 for Phase 2, 111 for Phase 3 with severe COVID-19 pneumonia randomized 2:1 in the Phase 2, and the results will inform the study design for the Phase 3. The study involves a minimum of 10 Brazilian centers. Following successful completion of Phase 2, Dompé has prepared a rapid transition into a Phase 3 program, to begin once data from Phase 2 are positively evaluated, and to be extended to multiple US centers.

References
REPAVID-19 Clinical Study (DDCM) #25351.664925/2020-86
Brazilian Health Regulatory Agency (ANVISA) http://portal.anvisa.gov.br/english
Diário Oficial da União http://www.in.gov.br/autenticidade.html

Repavid-19 sites list (City, State)

São Paulo (São Paulo)
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
- Hospital Vila Nova Star

Presidente Prudente (São Paulo)
- Santa Casa de Misericórdia de Presidente Prudente

Sao José do Rio Preto (São Paulo)
- Faculdade de Medicina de São José do Rio Preto 

Varginha (Minas Gerais)
- Hospital Humanitas

Salvador (Bahia)
- Hospital da Cidade
- Hospital General Ernesto Simões Filho- SESAB
- Hospital São Rafael. Rede D'or São Luiz

Brasilia (Distrito Federal)
- Instituto D'or Pesquisa e Ensino

Criciùma (Santa Catarina)
- Sociedade Literária e Caritativa Santo Agostinho - Hospital São José

About Dompé
Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy. Today, Dompé employs more than 800 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston.

Medical Affairs Contacts:
medical.info@dompe.com

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