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Trial - PACTR202010718451278


Column Value
Trial registration number PACTR202010718451278
Full text link
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

James Arkinstall

Contact
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

media@dndi.org

Registration date
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-10-14

Recruitment status
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

For Index Cases (treated patients from the ANTICOV Study) 1. Comes from household in accessible area 2. At least 1 Household Contact (HHC) currently residing at household with index 3. Contact details of HHC provided by index case 4. Majority (over 50%) of HHC provide consent and enrol in the ANTICOV-EPI study 5. Randomised to ANTICOV For Household contacts (not treated patients living with the Index patient) 6. Member of same household as index case (household defined as sharing same cooking area) during the conduct of the study 7. Resides in household with index case before index case illness onset. 8. Majority (over 50%) of HHC provide consent and enrol in the ANTICOV-EPI study

Exclusion criteria
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Exclusion criteria of household contacts 1. Inability to provide consent 2. Majority of all contacts of index in household do not enroll

Number of arms
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

3

Funding
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

DNDi

Inclusion age min
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

0

Inclusion age max
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Equatorial Guinea;Ghana;Kenya;Mozambique

Type of patients
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1500

primary outcome
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1) Seroconversion for SARS-CoV-2 IgM; IgA and IgG among household contacts and index case;2) RT-PCR SARS-CoV-2 positive results at Day 1 (index case)/D2(household contacts); 7; 14; 21; and Month 1 in household contacts and index case.;3) Secondary attack rate of infection and illness for household contacts from index cases

Notes
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (3.0) differs from found arms (4.0)

Phase
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

Arms
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 958, "treatment_name": "Paracetamol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]