Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sargramostim · 3 trials · 16 indications
Percentage of patients who experience any emergency room visit or hospitalization, or death
The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.
| Arm | Type | Description |
|---|---|---|
| Sargramostim Arm | EXPERIMENTAL | Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 |
| Placebo Arm | PLACEBO_COMPARATOR | Day 1 - 5: Placebo treatment in addition to standard of care for COVID-19 |
| Control Arm | ACTIVE_COMPARATOR | Standard of care for COVID-19 |
| Arm I (FRalpha peptide vaccine, sargramostim) | EXPERIMENTAL | Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo, sargramostim) | PLACEBO_COMPARATOR | Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Sargramostim | DRUG | All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days. |
| Placebo | DRUG | All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days. |
| Standard of care | DRUG | Standard of care for COVID-19 |
| Cyclophosphamide | DRUG | Given PO |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Multi-epitope Folate Receptor Alpha Peptide Vaccine | BIOLOGICAL | Given ID |
| Placebo Administration | OTHER | Given ID |
Inclusion Criteria: 1. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or a molecular test ≤5 days prior to randomization. The test should have been authorized by the relevant regulatory authority. 2. Have one or more of the following mild or moderate COVID-19 sy...
Sargramostim is an investigational drug being studied for COVID-19 and breast cancer, including bilateral breast carcinoma and triple-negative breast cancer. It is in Phase 2 clinical development for these indications. Sargramostim is not approved by the FDA and remains under clinical investigation.
Sargramostim is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with COVID-19 and certain breast cancers.
Sargramostim is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials are ongoing or completed to assess its effectiveness in treating COVID-19 and breast cancer conditions.
Sargramostim is being studied in three Phase 2 clinical trials. NCT03012100 evaluates a vaccine with GM-CSF in triple-negative breast cancer. NCT04411680 and NCT04707664 study Sargramostim in COVID-19 patients. These trials are conducted in the United States and Argentina.
Sargramostim is a monoclonal antibody, not GM-CSF itself. In clinical trials, it is studied alongside GM-CSF as a vaccine adjuvant. The drug is being tested for its potential role in treating COVID-19 and breast cancer, but it is distinct from GM-CSF.