Table 2.
Schedule of laboratory investigations.
| Visit | Visit 0 Screening (Day −7 to −1) |
Visit 1 Enrollment and randomization (Day 1) |
Visit 2 (4 wks) | Visit 3: (8 wks) | Visit 4 (12 wks) | Interim analysis | Visit 5:(16 wks) |
Visit 6 Intervention completion (24 wks) |
Visit 7: Part 1 completion (28 wks) |
|---|---|---|---|---|---|---|---|---|---|
| CBC: blood hemoglobin, total and differential count, platelets Erythrocyte sedimentation rate (Westergren) |
X | X | X | ||||||
| D-dimer | X | X | X | ||||||
| LFT: serum liver enzymes-SGOT, SGPT, alkaline phosphatase Serum albumin, globulin, bilirubin |
X | X | X | ||||||
| RFT: blood urea nitrogen Serum creatinine |
X | X | X | ||||||
| Blood sugar profile (BSL fasting and HbA1c) | X | X | X | ||||||
| Urine routine | X | X | X | ||||||
| +Urine pregnancy test | X | X | X | X | X | X | X | ||
| #RT-PCR throat/nose swab testing for SARS-CoV2 RNA | X | X | X | X | X | X | X | ||
| SARS- CoV-2 S1, RBD and N Specific IgG | X | X | X | X | X | X | X | ||
| sVNT | X | X | X | ||||||
| SNT (Wuhan isolate USA-WA1/2020 and Delta variant B1.617.2) | X | X |
#
RT-PCR throat nose swab test will be repeated in participants in case of development of any symptoms during the study duration.
+
for female participants.
Additional studies on measurement of secretory IgA and T cell responses are planned on a subset of the participants.