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Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
Phase 1, PHASE2 trial testing Best Practice in Hematopoietic and Lymphoid Cell Neoplasm in 2 participants. Completed in 27 October 2021.
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 7 January 2021 |
| Primary completion | 26 August 2021 |
| Estimated completion | 27 October 2021 |
| Sites | 1 location across United States |
City of Hope Medical Center
18 and older, any sex, with Hematopoietic and Lymphoid Cell Neoplasm or Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Leflunomide, SOC) | NA |
Defined as time from start of treatment to \>= 2-point change in clinical status on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Leflunomide, SOC) | 9.5 | 5 – 14 |
Time from start of treatment to peripheral capillary oxygen saturation (SpO2) \> 93% on room air.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Leflunomide, SOC) | 6.5 | 1 – 12 |
Indicate the participants who were hospitalized within first 90 days following start of treatment assessed.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Leflunomide, SOC) | 2 |
Indication the participants who were required mechanical ventilation at any time from start of treatment through 90 days post.
| Group | Value | 95% CI |
|---|---|---|
| Phase I (Leflunomide, SOC) | 0 |
Time frame: Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I (Leflunomide, SOC) |
|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | — |
| COVID-19 | Infections and infestations | — |
| LYMPHOCYTE COUNT DECREASED | Investigations | — |
| PLATELET COUNT DECREASED | Investigations | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | — |
| HYPOCALCEMIA | Metabolism and nutrition disorders | — |
| DIZZINESS | Nervous system disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — |
| HYPERTENSION | Vascular disorders | — |
| HYPOTENSION | Vascular disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| DYSPHAGIA | Gastrointestinal disorders | — |
| FATIGUE | General disorders | — |
| FEVER | General disorders | — |
| GENERALIZED EDEMA | General disorders | — |
| NON-CARDIAC CHEST PAIN | General disorders | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | — |
| NEUTROPHIL COUNT DECREASED | Investigations | — |
| WHITE BLOOD CELL DECREASED | Investigations | — |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | — |
| HYPOKALEMIA | Metabolism and nutrition disorders | — |
| OBESITY | Metabolism and nutrition disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | — |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | — |
| ANOSMIA | Nervous system disorders | — |
| DYSGEUSIA | Nervous system disorders | — |
| HEADACHE | Nervous system disorders | — |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | — |
| INSOMNIA | Psychiatric disorders | — |
| NOCTURIA | Renal and urinary disorders | — |
| URINARY INCONTINENCE | Renal and urinary disorders | — |
| VAGINAL DRYNESS | Reproductive system and breast disorders | — |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | — |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | — |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — |
Data from ClinicalTrials.gov NCT04532372 adverse events section.
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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