Table 2.
Survey Results Regarding Criteria for Allocation of EUA Remdesivir at US Hospitals
| Survey Questions | No. (%) Responses | ||
|---|---|---|---|
| 1. In addition to the minimum use criteria outlined by the FDA EUA statement identifying severe disease, what other minimum criteria were established for inclusion? (n = 66) | |||
| Confirmed positive test for SARS-CoV-2 | 61 (92) | ||
| Requiring supplemental oxygen | 49 (74) | ||
| Short symptom duration (eg, ≤10 days) | 24 (36) | ||
| Abnormal chest imaging | 23 (35) | ||
| Recent hospitalization (eg, <7 days ago) | 23 (35) | ||
| Requiring mechanical ventilation or ECMO | 19 (29) | ||
| Treated in an intensive care unit | 2 (3) | ||
| Other | 4 (6) | ||
| 2. Which of the following were used as exclusion criteria? (n = 66) | |||
| ALT >5 × upper limit of normal | 56 (85) | ||
| eGFR <30 mL/min or receiving renal replacement therapy | 40 (61) | ||
| Expected immediate short life expectancy such that administration of remdesivir is highly unlikely to change the clinical outcome | 31 (47) | ||
| Already improving on current treatment/supportive care regimen | 22 (33) | ||
| Previous receipt of remdesivir (in clinical trial or via EUA) | 19 (29) | ||
| Eligible for compassionate use remdesivir (ie, pediatric or pregnant patient) | 15 (23) | ||
| Duration of mechanical respiration longer than specified number of days | 13 (20) | ||
| Enrolled in clinical trial | 13 (20) | ||
| Life expectancy of <6 months | 11 (17) | ||
| Duration of hospitalization (>n days) | 10 (15) | ||
| DNR and/or DNI status | 9 (14) | ||
| Duration of ECMO (>n days) | 7 (11) | ||
| Significant vasopressor requirement | 3 (4) | ||
| Age above a certain cutoff (eg, age >65) | 1 (1) | ||
| Other | 7 (11) | ||
| 3. Which of the following factors were used to prioritize use of EUA remdesivir when demand exceeds supply? (n = 66) | |||
| “First come, first served” | 31 (47) | ||
| Patient factors: vital signs and/or oxygenation (see question 4) | 19 (29) | ||
| Patient factors: clinical course and/or other factors (see question 5) | 16 (24) | ||
| Random lottery | 15 (23) | ||
| Patient factors: laboratory parameters | 7 (11) | ||
| Patient factors: comorbidities and/or demographics | 3 (4) | ||
| Essential worker status | 3 (4) | ||
| Socioeconomic disadvantage | 0 | ||
| Validated scoring system | 0 | ||
| Other (eg, demand has not yet exceeded supply, tiered system, pregnant women and children, or not applicable) | 11 (17) | ||
| Higher Priority | Lower Priority | Not Used | |
| 3a. Patient factors: vital signs and/or oxygenation (n = 19) | |||
| Elevated heart rate | 1 (5) | 5 (26) | 13 (68) |
| Elevated respiratory rate | 4 (21) | 3 (16) | 12 (63) |
| Hypotension | 3 (16) | 4 (21) | 12 (63) |
| Low Pao2/Fio2 | 10 (53) | 2 (10) | 7 (37) |
| Mechanical ventilation | 14 (74) | 4 (21) | 1 (5) |
| High-flow nasal cannula | 13 (68) | 3 (16) | 3 (16) |
| Nasal cannula | 9 (47) | 7 (37) | 3 (16) |
| ECMO requirement | 7 (37) | 3 (16) | 9 (47) |
| Prioritized | Not Used | ||
| Longer Duration | Shorter Duration | ||
| 3b. Patient factors: clinical course and/or other factors (n = 16) | |||
| Duration of hospitalization | 0 | 9 (56) | 7 (44) |
| Duration of intubation | 0 | 12 (75) | 4 (25) |
| Duration of symptoms | 1 (6.3) | 9 (56) | 6 (37) |
| Duration of ECMO | 1 (6.3) | 8 (50) | 7 (44) |
| No. (%) Responses | |||
| 4. Have you made adjustments to your original criteria? (n = 66) | |||
| Yes | 31 (47) | ||
| No | 35 (53) | ||
| 4a. What were the changes? (n = 31) | |||
| Loosening oxygenation criteria or allowing use in less critically ill patients | 10 (32) | ||
| Removal of cutoffs related to symptom duration or time since positive test | 6 (19) | ||
| Prioritizing earlier use or adding a shorter cutoff from onset of symptoms and/or positive test | 6 (19) | ||
| Removal of exclusion criteria related to poor renal function and/or RRT | 5 (16) | ||
| Changes in process or prioritization | 5 (16) | ||
| Clarifications to duration of treatment with remdesivir | 3 (10) | ||
| More strict oxygenation criteria | 2 (6) | ||
| Removal of exclusion for poor hepatic function | 1 (3) | ||
| Other or not clearly indicated | 6 (19) |
Abbreviations: ALT, alanine aminotransferase; DNI, do not intubate; DNR, do not resuscitate; ECMO, extracorporeal membrane oxygenation; eGFR, estimated glomerular filtration rate; EUA, emergency use authorization; FDA, Food and Drug Administration; Pao2/Fio2, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen; RRT, renal replacement therapy; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.