COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04328285

Elisabeth Botelho-Nevers, MD, PhD

Arnauld Garcin, Arnauld.Garcin@chu-st-etienne.fr (PI email not reported)

2020-03-31

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - adult healthcare workers (hcws) (for instance physicians, nurses, assistant nurses, dentists, physiotherapists, midwives, etc.) - hcw involved at the time of enrolment in the care and the management of patients with confirmed or suspected sars-cov-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities. these hcws have prolonged or repeated close contact to these patients. - hcw tested negative for hiv - hcw affiliated to the french health insurance system - hcw women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of lpv/r treatment - covidaxis 2) - willing to comply to study design and the follow-up - consent form signed

for covidaxis 1: - hcw with positive sars-cov-2 rt-pcr of nasopharyngeal swab at the inclusion visit. - hcw with past history of confirmed sars-cov-2 infection - hcw with positive sars-cov-2 serology at the inclusion visit - hcw with comorbidities such as hypothyroidism that need hormonal substitution, or retinopathy or with prior intermittent porphyria, or chronic renal failure (glomerular filtration rate < 30ml/min) or prior hepatic failure or psoriasis. - hcw with prior diagnosis of glucose-6-phosphate dehydrogenase (g6pd) deficiency - hcw with known hypersensitivity/allergy to hcq - hcw with baseline qtc interval > 450ms in men or > 460ms in women and qtc <320 ms (both gender) - hcw with personal or family history of long qt syndrome, torsades de pointes, or sudden death - pregnant hcw - breastfeeding hcw - hcw taking comedications known to have interactions with hcq according to the official characteristics of the product for covidaxis 2: - hcw with positive sars-cov-2 rt-pcr of nasopharyngeal swab at the inclusion visit. - hcw with past history of confirmed sars-cov-2 infection - hcw with positive sars-cov-2 serology at the inclusion visit - hcw with comorbidities such as chronic hcv infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or known to have hypercholesterolemia hypertriglyceridemiaor chronic renal failure (glomerular filtration rate < 30ml/min) or prior hepatic failure - hcw with known hypersensitivity/allergy to lpv/r - hcw with baseline qtc interval > 450ms in men or > 460ms in women and qtc <320 ms (both gender) - hcw with personal or family history of long qt syndrome, torsades de pointes, or sudden death - pregnant hcw - breastfeeding hcw - hcw taking comedications known to have interactions with lpv/r according to the official characteristics of the product

4

Centre Hospitalier Universitaire de Saint Etienne

18

None

France

Health workers

N/A

118

Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]