Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen]

NCT05060666 | Unknown Phase 3

• 2 other identifiers: PREVENT-COVID2021-002445-15
• Study Type: interventional
• Target: 412
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Prevent-COVID study is a prospective, multicenter, randomized, two-armed, placebo-controlled, double-blind, interventional study in which the efficacy and safety of ivermectin in COVID-19 post-exposure prophylaxis (PEP) is examined in adult, close family contacts living in the household of a subject suffering from COVID-19.

Conditions

Covid19

Keywords

COVID-19 post-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• COVID-19 disease

  Occurrence of a COVID-19 disease up to the final visit (day 14), defined as the presence of the clinical condition according to the RKI case definition (acute respiratory symptoms of any severity OR new loss of smell and taste occurred OR illness-related death) AND a positive SARS-CoV-2 PCR test on the day the symptoms were determined (+/- 4 days)

  Day 14

Secondary Outcomes (3)

• Adverse events and side effects

  14 days

• Type, number and severity of symptoms

  14 days

• Severity of the COVID-19 disease

  14 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

2 doses of ivermectin at day 0 and day 2

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

2 doses of placebo at day 0 and day 2

Drug: Placebo

Interventions

Ivermectin DRUG

2 doses of Ivermectin will be administered with 48 hours time interval. The dosage is based on body weight calculated as follows: * 15 mg for 40-60 kg = 5 tablets à 3 mg * 18 mg for 60-80 kg = 6 tablets à 3 mg * 24 mg for \> 80 kg = 8 tablets à 3 mg each This corresponds to an ivermectin dose of about 300 µg / kg.

Also known as: Driponin, ATC-code P02CF01, Substance code SUB12089MIG

Ivermectin

Placebo DRUG

An analogous number of tablets is administered for placebo: * 5 tablets for 40-60 kg * 6 tablets for 60-80 kg * 8 tablets for \> 80 kg The size, appearance, smell and taste of the tablets of placebo are identical to Ivermectin.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of at least 18 years
• adult subject living in the same household as a related COVID-19 patient (index person)

You may not qualify if:

• index person has COVID-19 symptoms for more than 5 days at enrolment
• known past COVID-19 or current infection confirmed by positive SARS-CoV-2 PCR test at enrolment
• symptoms at enrolment indicating COVID-19: increased body temperature OR acute respiratory symptoms of any severity OR newly occuring loss of taste or smell OR ague OR sumulatneously occuring headache and body ache
• known contraindications to the use of the study medication (in alignemnt with current summary of product characteristics of Driponin®)
• known chronic obstructive pulmonary disease
• known acute or chronic hepatitis B or C or other clinically recognizable or known liver dysfunction
• known HIV infection or AIDS
• known symptomatic allergic rhinitis
• current (inlcuding up to 24 hours before enrolment) or planned (during next 14 days) therapy with non-steroidal anti-inflammatory drugs, other pain medication (e.g., ASS (including prophylactic use), metamizol)
• recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with systemic steroids
• recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with systemic immunosuppressive drugs
• known or clinically suspected disturbance of the blood-brain-barrier (e.g., ABCB-1 (=MDR1) mutation) as well as history of neurotoxic effects by ivermectin or other substrates/inhibitors of the para-glycoprotein (P-gp)
• known hypersensitivity/intolerance to the study drug or any of its exicpients, in particular ivermectin, microcrystalline cellulose, pre-agglutinated starch, butyl hydroxyanisole or magnesium stearate
• pregnancy or lactation
• women of child-bearing potential planning to become pregnant or not using effective mehods of contraception

Sponsors & Collaborators

• Infectopharm Arzneimittel GmbH: lead
• GKM Gesellschaft für Therapieforschung mbH: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: September 29, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 2, 2021

Record last verified: 2021-11