Trial results
$IVVD — VYD2311
Invivyd, Inc. (IVVD) VYD2311: trial results in COVID-19 pre-exposure prophylaxis, 2026.
The catalyst
"DECLARATION sVNA titers, PK, and safety data expected in October 2026; COVID-19 events to remain blinded and DECLARATION planned to serve as the ongoing, confirmatory trial"
— Invivyd, Inc., 8-K filed 2026-09-29 · the filing. Checked word for word against the stored document when this page was built; a sentence that did not check out would not be here.
- Event id
IVVD-VYD2311-2026- Company
- Invivyd, Inc.
- Kind
- Trial results
- Indication
- COVID-19 pre-exposure prophylaxis
- Window
- 2026-10-01 – 2026-10-31
- Status
- bar_published
The bar
Published 2026-09-29 22:02 ET, before the event. The text below is the hashed text: paste it into the verify page and your browser will recompute the same digest.
At a glance
Pass if: The readout should not exceed the prior VYD2311-related safety benchmark · The reported relative risk reduction must reach the lower end of the company's stated target ag…
9 items we could not source — full detail below
EVENT IVVD-VYD2311-2026 SCORED SET ITT FLOOR safety_grade_floor The readout should not exceed the prior VYD2311-related safety benchmark. BAR efficacy_target_floor The reported relative risk reduction must reach the lower end of the company's stated target against placebo.
- SHA-256
13f46bbcf995a82f3d6eb21cc6c5c02936aa8734e66f307a9a93ac8564f10b7a- Frozen
- yes
- Public post
- https://x.com/i/web/status/2105115978937852174
Criteria as committed
Floor — all must pass
| Id | Field | Test | As written |
|---|---|---|---|
safety_grade_floor |
VYD2311-related adverse-event maximum grade |
<= 2 |
The readout should not exceed the prior VYD2311-related safety benchmark. |
Bar — all must pass
| Id | Field | Test | As written |
|---|---|---|---|
efficacy_target_floor |
relative risk reduction in PCR+ symptomatic COVID-19 versus placebo |
>= 70 |
The reported relative risk reduction must reach the lower end of the company's stated target against placebo. |
What we could not source before the event
- No CT.gov study record or single registered trial matching VYD2311 is present.
- No document states the primary analysis population, so scored_set is null.
- No public protocol states the efficacy success margin, alpha, multiplicity plan, confidence-bound rule, or event-count trigger.
- No exact readout date is printed.
- No complete arm-level efficacy table, confidence intervals, p-values, event counts, or final estimand are provided.
- Enrollment is inconsistent across company descriptions: 1770, approximately 2,301, and approximately 2,400.
- The manual options snapshot and comparator file contain no populated data.
- No numeric secondary-endpoint thresholds or numeric veto criteria are printed.
- analysis population: ITT — ESTIMATED — no document states the primary result's population; the documents describe a randomized comparison, analysed on every randomized patient unless the protocol says otherwise; change it in the editor if the protocol says otherwise
Verdicts
No verdict has been published for this event yet.