Clinical trial · Interventional
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
NCT04447235CI-TRIAL-00060197TITANterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): futility analysis has demonstrated no difference between arms
Summary
Brief summary (as posted)
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Coronavirus Infection | — | UNRESOLVED | — |
| COVID | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivermectin | Drug | — | UNRESOLVED |
| Losartan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- ARM A: Placebo
- description
- Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- ARM B: Ivermectin plus losartan
- description
- Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days
- interventionNames
- Drug: Ivermectin
- Drug: Losartan
Primary outcomes (1)
- measure
- Incidence of severe complications due COVID-19 infection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years of age * Ability to understand and sign informed consent * Biopsy-proven diagnosis of previous cancer (solid or hematologic disease) * Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality. * Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan. * ECOG performance status 0 to 2 * Patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by: * Hemoglobin ≥ 9.0 g / dL * Leukometry\> 2,000 / mm3 * Absolute neutrophil count ≥ 1,500 / mm3 * Platelet count ≥ 100,000 / mm3 * Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula. * Total bilirubin \<3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome. * Aspartate aminotransaminase (AST) \<3.0 x LSN. * Alanine aminotransaminase (ALT) \<3.0 x ULN. Exclusion Criteria: * Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB). * Patients who presents with severe conditions at the time of diagnosis requiring ICU admission. * Prior reaction or intolerance to an ARB or ACE inhibitor. * Blood pressure less than 110/70 mmHg at presentation * Potassium greater than 5.0 mEq / L * Pregnancy or breastfeeding * Prior reaction to Ivermectin. * Patient currently enrolled in another research protocol
References
Publications (0)
Data not yet available
No reference posted for this study.