Table 3.

Schedule of enrolment, interventions, and assessments.

	Study period
	Enrolment	Allocation	Post-allocation					Close-out
Timepoint	D −07to −01	D 01	W 04	W 08	W 12	W 16	W 24	W 28
Enrolment:
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions*:
[Daily dosing of placebo or Ashwagandha]
Assessments:
Concomitant illness	X	X	X	X	X	X	X	X
Randomization		X
Complete physical examination	X	X	X	X	X	X	X	X
WHO QOL BREF, HR-BHF		X			X		X	X
Vital signs	X	X	X	X	X	X	X	X
Ayurvedic phenotype: prakriti		X
Ayurvedic assessment: dhatu sarata, srotasa pariksha		X	X	X	X	X	X	X
ECG, Chest-X ray	X						X
Study drug dispensation,		X		X		X
Compliance			X	X	X	X	X	X
Mobile App–Kavach–self reported questionnaire
Blood hemoglobin, total and differential count, platelets, ESR, SGOT, SGPT, alkaline phosphatase, serum albumin, globulin, bilirubin, blood urea nitrogen, serum creatinine,	X				X		X
D-dimer	X				X		X
HbA1c, blood sugar fasting, 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 (variants-USA-WA1/2020 and Lineage B.1.617.2; delta variant)					X			X
Completion and outcome report								X
AE

Additional studies on measurement of secretory IgA and T cell responses are planned on a subset of the participants.