Coordinating a Triple-Blind COVID-19 Nasal Spray Study with Clinion EDC and RTSM
Overview
An FMCG (fast-moving consumer goods) company’s life sciences division partnered with Clinion to support a multicentric, triple-blind, randomized, placebo-controlled trial testing a nasal spray for preventing SARS-CoV-2 infection in household caregivers of COVID-19 positive individuals, aged 12 to 99. The public trial record classifies the study type as Ayurveda, though project input lists it as allopathic; both are noted here given the discrepancy.
Patients were randomized to the nasal spray or a placebo by computer-generated sequence with centralized concealment, with participants, investigators, and outcome assessors all blinded, per the registry record. Over a 30-day intervention period plus a 7-day safety follow-up, the trial tracked infection rates, viral load differences between arms, disease severity, and safety data, ultimately enrolling 510 subjects against a target of 480.
Clinion EDC and RTSM were used together to support the trial’s randomization and data capture needs across its 7 participating sites in India. RTSM helped manage the trial’s randomized, blinded allocation, while EDC helped the study team capture infection, severity, and safety data consistently across sites during an active phase of the pandemic.
Study Snapshot
Industry
FMCG
Client
FMCG sponsor (life sciences division)
Study Type
Interventional
Therapeutic Area
Infectious Disease (COVID-19
Study Phase
N/A, per registry record
Study Design
Multicentric, randomized, placebo-controlled, triple-blind study
Randomization
Triple blind, computer-generated randomization, centralized concealment, per registry record
Region
India
Site Count
7 sites
Submission
DCGI, per project input
Study Duration
6 months, per registry record and project input
Products Provided
Challenges
Keeping COVID-19 Prevention Data Consistent Across Randomized, Blinded Sites
This trial combined a randomized, triple-blind, placebo-controlled design with a broad range of infection, severity, and safety outcomes, all captured within a compressed timeframe and across a real-world household exposure setting rather than a controlled inpatient environment. The challenge was capturing this consistently across 7 sites during an active phase of the pandemic.
01
Preserving Triple-Blind Allocation Outside a Clinical Setting
The trial randomized household caregivers to the nasal spray or a placebo by computer-generated sequence, with centralized concealment and participant, investigator, and outcome assessor all blinded, per the registry record. Maintaining this blind in a household exposure setting, rather than a controlled clinical environment, created a need for a randomization setup robust enough to preserve concealment outside a traditional inpatient trial.
02
Coordinating Infection, Severity, and Safety Data Within a 30-Day Window
Endpoints spanned infection rates, viral load differences between arms, disease severity, and safety and tolerability data, all captured within a 30-day intervention period plus a 7-day safety follow-up, per the registry record. Coordinating this range of data within such a compressed timeframe created a need for a structured, responsive data capture approach.
03
Scaling Data Capture Across Sites Mid-Pandemic
Conducted across 7 sites in three states during an active phase of the pandemic, the trial needed consistent enrollment, randomization, and follow-up data capture at every site, ultimately enrolling more subjects than planned. This created a need for a data environment that could scale with enrollment while staying consistent across sites.
Solutions
Connecting Randomization and COVID-19 Outcome Data with Clinion EDC and RTSM
Clinion EDC and RTSM helped the study team manage randomization, blinded assignment, infection-status data, and safety review in one connected trial workflow. This gave the sponsor better control over subject progression across the 7-site prevention study.
Outcomes
Core Results
Clinion EDC and RTSM helped the sponsor manage a blinded COVID-19 prevention study with clearer randomization control and more consistent data capture.
Blinded Allocation Control
RTSM supported randomized nasal spray and placebo assignment across sites.
Infection-Status Visibility
EDC workflows helped capture test results and COVID-19 status across the 30-day study period.
Multisite Data Consistency
A shared data environment helped 7 sites across three states capture trial data the same way, even as enrollment grew beyond its original target.
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Compliance
Fully Compliant with Global Standards
