COVID-19 Prophylaxis
Primary
· From Day 1 to Day 28
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 30 | |
| Placebo | 105 |
Last reviewed · How we verify
NCT05305560: SAIVE
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
Completed
Phase 2
Results posted
Last updated 31 December 2024
What this trial tests
Phase 2 trial testing Ivermectin Tablets in COVID-19 in 400 participants. Completed in 13 October 2022.
Timeline
25 March 2022
Primary endpoint
15 September 2022
15 September 2022
13 October 2022
Quick facts
| Lead sponsor | MedinCell S.A |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 400 |
| Start date | 25 March 2022 |
| Primary completion | 15 September 2022 |
| Estimated completion | 13 October 2022 |
| Sites | 1 location across Bulgaria |
Drugs / interventions tested
- Ivermectin Tablets — full drug profile →
- Matching placebo tablets — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
MedinCell S.A
Who can join
Adults 18 to 65, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
COVID-19 Symptoms Development
Secondary
· From Day 1 to Day 28
Number of symptomatic Participants according to the WHO COVID-18 scale
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 28 | |
| Placebo | 97 |
COVID-19 Prophylaxis Timeframe
Secondary
· From Day 1 to Day 28
Time to change from baseline in negative RT-PCR to positive RT-PCR
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 9 | ± 1.39 |
| Placebo | 8.10 | ± 2.14 |
COVID-19 Hospitalisations
Secondary
· From Day 1 to Day 56
Proportion of COVID-19 related hospitalisations
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 0 | |
| Placebo | 0 |
COVID-19 Mortality
Secondary
· From Day 1 to Day 56
Proportion of COVID-19 related mortality
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 0 | |
| Placebo | 0 |
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
Secondary
· 56 days
Descriptive comparison of AE rates and severity/seriousness between IVM and placebo
Adverse events
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 49 | |
| Placebo | 109 |
Serious adverse events
| Group | Value | 95% CI |
|---|---|---|
| Active IMP | 0 | |
| Placebo | 0 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 56 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Active IMP
Serious: 0/200 (0%)
Deaths: 0/200
Placebo
Serious: 0/199 (0%)
Deaths: 0/199
Other adverse events (16 terms — click to expand)
| Reaction | System | Active IMP | Placebo |
|---|---|---|---|
| COVID-19 | Infections and infestations | — | — |
| C-reactive protein increased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Palpitations | Cardiac disorders | — | — |
| Dysmenorrhea | Reproductive system and breast disorders | — | — |
| Fatigue | General disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Hyperlipidemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Vertigp | Ear and labyrinth disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Basophil count increased | Investigations | — | — |
| Body temperature increased | Investigations | — | — |
Data from ClinicalTrials.gov NCT05305560 adverse events section.
Sponsor's own description
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Role of Cyclodextrins in COVID-19 Therapy-A Literature Review.
Almeida B, Domingues C, Mascarenhas-Melo F, Silva I, et al · · 2023 · cited 17× · PMID 36769299 · DOI 10.3390/ijms24032974 -
A Pilot, Randomised, Placebo-Controlled, Double-Blind Trial of a Single Oral Dose of Ivermectin for Post-Exposure Prophylaxis of SARS-CoV-2.
Wagstaff KM, Stein MS, Herschtal A, Rajter JJ, et al · · 2025 · PMID 41012540 · DOI 10.3390/pharmaceutics17091205
Verify or expand the search:
- PubMed search for NCT05305560
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other MedinCell S.A trials
Trials by the same sponsor.
- NCT04632706 — Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05305560 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MedinCell S.A
- Last refreshed: 31 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05305560.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing