Trial Outcomes & Findings for USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 (NCT NCT04425850)

NCT ID: NCT04425850

Last Updated: 2020-10-19

Results Overview

Number of participants testing positive for COVID-19 after inclusion in each arm

• Recruitment status: COMPLETED
• Target enrollment: 229 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2020-10-19

Participant Flow

Health personnel

Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out. It includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion.

Participant milestones

Measure	IVER+ Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal)	IVER- Standard prophylactic measures and PPE only
Overall Study STARTED	131	98
Overall Study COMPLETED	131	98
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19

Baseline characteristics by cohort

Measure	IVER+ n=131 Participants Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. PPEs used as suggested by OMS. iota carrageenan: topical use on nasal mucosae Ivermectin: Topical use on oral mucosae	IVER- n=98 Participants Same as IVER+ They will follow PPEs suggestions, only.	Total n=229 Participants Total of all reporting groups
Age, Continuous	42 years n=93 Participants	39 years n=4 Participants	40 years n=27 Participants
Sex: Female, Male Female	70 Participants n=93 Participants	72 Participants n=4 Participants	142 Participants n=27 Participants
Sex: Female, Male Male	61 Participants n=93 Participants	26 Participants n=4 Participants	87 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	131 Participants n=93 Participants	98 Participants n=4 Participants	229 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	131 Participants n=93 Participants	98 Participants n=4 Participants	229 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Argentina	131 Participants n=93 Participants	98 Participants n=4 Participants	229 Participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Hispanic

Number of participants testing positive for COVID-19 after inclusion in each arm

Outcome measures

Measure	IVER+ n=131 Participants Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)	IVER- n=98 Participants Standard prophylactic measures and PPEs only
Number of Infected Subjects	0 Participants	11 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Hispanic

Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression

Outcome measures

Measure	IVER+ n=131 Participants Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)	IVER- n=98 Participants Standard prophylactic measures and PPEs only
Adverse Events Other Than Those Resulting From Contagion or Disease Progression	0 Participants	0 Participants

Adverse Events

IVER+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IVER-

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IVER+ n=131 participants at risk Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal).	IVER- n=98 participants at risk Standard prophylactic measures and PPEs only
Infections and infestations Contagion	0.00% 0/131 • 30 days Medical examination Chart of adverse events filled in by subjects	11.2% 11/98 • Number of events 11 • 30 days Medical examination Chart of adverse events filled in by subjects

Additional Information

Dr. Héctor Carvallo

Eurnekian Public Hospital

Phone: 54144800949

Email: hymcarvallo@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place