COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14678

FELIX ALAKALOKO

felixalakaloko@gmail.com

2021-02-10

Not recruiting

RCT

Randomized

Crossover

Blind label

multi-center

Prevention

1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years and above. 4. Close contacts (6 meters with no PPE) to confirmed RT-PCR positive individual. 5. Ability to take oral medication and be willing to adhere to the study regimen 6. For females of reproductive potential: a negative pregnancy test and LMP date. 7. Agreement to adhere to Lifestyle Considerations throughout study duration.

1. Current use of cytochrome P4 enzyme inducers such as azole group of oral antifungal medication (Ketoconazole, Itraconazole), Warfarin 2. Non exposure to Covid-19 patients 3. Those who refuse to give informed consent 4. Pregnant and lactating women will be excluded because Ivermectin is known to cross the blood placenta barrier and its effect on the unborn fetus has not been fully evaluated. Although there is no evidence of teratogenicity in the literature, the doses envisaged will be higher than that used in management of onchocerciasis. Safety first is our mantra. 5. Those with a known hypersensitivity to Ivermectin. 6. Those subjects who have had treatment with any investigational drug within 2 weeks prior to randomization. 7. Children, stigmatized population, institutionalized persons, Previously diagnosed and recovered from COVID-19. 8. Severely ill patients such as patients on ventilators, hepatic or renal impairment or unconscious. 9. Patients on known drugs that can have serious interactions with the trial drug including barbiturates (such asphennobarbital, butalbital), benzodiazepines (such as clonazepam, lorazepam), sodiumoxybate (GHB), valporic acid and herbal medicines 10. Treatment with another investigational drug.

2

FEDERAL GOVERMENT OF NIGERIA

18

85

Nigeria

Close contacts to covid patients

N/A

2100

The purpose of this study is to examine the efficacy and safety of Ivermectin in the prevention of COVID 19 following exposure and to determine the number of participants who will develop clinical COVID-19. 1)The Primary outcome measure is the onset of clinical disease(symptoms such as Fever ;Cough; Sore Throat; Myalgia; Diarrhea; Shortness of Breath within 14 days after enrollment. subsequently confirmed by RT-PCR(New infection)2).Number developing COVID-19 clinical disease

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]