RBR-3k4wxb Evaluation of the use of Hydroxychlorochine in Chinese flu

Date of registration: 05/05/2020 ^(mm/dd/yyyy)
Last approval date : 05/05/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1250-7492

• Public title:

  en

  Evaluation of the use of Hydroxychlorochine in Chinese flu

  pt-br

  Avaliação do uso da Hidroxicloroquina em casos de gripe chinesa

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • Número do CAAE: 30585020.2.0000.0008
    Issuing authority: Plataforma Brasil
  • Número do Parecer do CEP: 3.982.682
    Issuing authority: Comissão Nacional de Ética em Pesquisa

Sponsors

• Primary sponsor: Hospital Santo Antônio
• Secondary sponsor:
  • Institution: Hospital Santo Antônio
• Supporting source:
  • Institution: Hospital Santo Antônio

Health conditions

• Health conditions:

  en

  non specified coronavirus infection/ coronavirus

  pt-br

  Infeccao por coronavirus, nao especificada /Coronavirus

• General descriptors for health conditions:

  en

  A00-B99 I - Certain infectious and parasitic diseases

  pt-br

  A00-B99 I - Algumas doenças infecciosas e parasitárias

• Specific descriptors:

Interventions

• Interventions:

  en

  1. Control group - 15 participants The Control group will receive proper COVID19 treatment but will not receive hydroxychloroquine, chloroquine, azithromycin, or another macrolide. PT-BR EN 2. G1 - 15 participants This group will receive proper COVID19 treatment and hydroxychloroquine 400mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 400mg + azithromycin 500mg once each, orally, or enterally, for 10 days or negative PCR, what comes first. 3. G2 - 15 participants This group will receive proper COVID19 treatment and hydroxychloroquine 200mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 200mg + azithromycin 500mg once each, orally, or enterally, for 10 days or negative PCR, what comes first.

  pt-br

  1. Grupo controle - 15 participantes. O grupo controle receberá tratamento sintomático para COVID-19, mas não deverá receber hidroxicloroquina, cloroquina, azitromicina ou outros macrolídeos. 2. G1 - 15 participantes. O grupo receberá, além tratamento apropriado para COVID-19, hidroxicloroquina 400 mg + azitromicina 500 mg 2 vez ao dia D0, via oral ou enteral e doses subsequentes hidroxicloroquina 400 mg + azitromicina 500 mg 1 vez ao dia via oral ou enteral por um período de 10 dias ou zeragem de carga viral no rt-PCR 3. G2 - 15 participantes. O grupo receberá, além tratamento apropriado para COVID-19, hidroxicloroquina 200 mg + azitromicina 500 mg 2 vez ao dia D0, via oral ou enteral e doses subsequentes hidroxicloroquina 200 mg + azitromicina 500 mg 1 vez ao dia via oral ou enteral por um período de 10 dias ou zeragem de carga viral no rt-PCR

• Descriptors:

  en

  D03.633.100.810.050.180.350 Hydroxychloroquine

  pt-br

  D03.633.100.810.050.180.350 Hidroxicloroquina

  es

  D03.633.100.810.050.180.350 Hidroxicloroquina

  en

  D02.540.576.500.992.050 Azithromycin

  pt-br

  D02.540.576.500.992.050 Azitromicina

  es

  D02.540.576.500.992.050 Azitromicina

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 05/01/2020 ^(mm/dd/yyyy)
• Date last enrollment: 11/30/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  45	-	18 Y	0 -

• Inclusion criteria:

  en

  Positive RT-PCR; age> 18 years; discrete classification (without signs of dyspnea, and oximetry greater than 93%)

  pt-br

  RT-PCR positivo; idade >18 anos; classificação leve (sem sinais de dispneia, e oximetria maior que 93%)

• Exclusion criteria:

  en

  Need for ICU on day 0; allergy to hydroxychloroquine or azithromycin; retinopathy; G6PD deficiency; QT extension; lactation; pregnancy; hepatic insufficiency; acute renal failure; patients who did not sign the informed consent

  pt-br

  Necessidade de UTI no dia 0; alergia à hidroxicloroquina ou azitromicina; retinopatia; deficiência G6PD; prolongamento QT; lactação; grávidas; insuficiência hepática; insuficiência renal aguda; pacientes que não assinaram consentimento informado

Study type

• Study design:

  en

  Randomized, open, controlled, three arms treatment clinical trial

  pt-br

  Ensaio clinico de tratamento randomizado- controlado, aberto, paralelo, com três braços

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	3	Open	Randomized-controlled	2

Outcomes

• Primary outcomes:

  en

  Negative viral load; RT-PCR was taken from a negative oropharynx swab; the RT-PCR value must be literally zero (0) for the patient to be considered cured

  pt-br

  Negativação carga viral; RT-PCR colhido a partir de swab de orofaringe negativa; o valor da RT-PCR deverá ser literalmente zero (0) para paciente ser considerado curado

• Secondary outcomes:

  en

  No secondary outcomes

  pt-br

  Sem desfechos secundários

Contacts

• Public contact
  • Full name: Marcos Aurelio Barboza de Oliveira
  • • Address: Av. dos Flamboyants, 2145
    • City: Sinop / Brazil
    • Zip code: 78550-144
  • Phone: +55-066-35171800
  • Email: maboliveira@gmail.com
  • Affiliation: Hospital Santo Antônio
   
• Scientific contact
  • Full name: Marcos Aurelio Barboza de Oliveira
  • • Address: Av. dos Flamboyants, 2145
    • City: Sinop / Brazil
    • Zip code: 78550-144
  • Phone: +55-066-35171800
  • Email: maboliveira@gmail.com
  • Affiliation: Hospital Santo Antônio
   
• Site contact
  • Full name: Marcos Aurelio Barboza de Oliveira
  • • Address: Av. dos Flamboyants, 2145
    • City: Sinop / Brazil
    • Zip code: 78550-144
  • Phone: +55-066-35171800
  • Email: maboliveira@gmail.com
  • Affiliation: Hospital Santo Antônio
   

Additional links:

• Download in ICTRP format