Actively Recruiting
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating CD388, a Long-Acting Antiviral, for Prevention of Influenza in Adolescents and Adults at Higher Risk
Led by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Updated on 2026-06-01
7500
Participants Needed
181
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 12 years of age or older at the time of informed consent.
- Provide written informed consent; for minors, parental consent and assent as applicable.
- Negative rapid antigen tests for influenza and COVID-19 before dosing.
- Weight at least 40 kilograms at screening.
- Body Mass Index (BMI) of 18 kg/m² or higher at screening.
- Able to comply with study procedures, use electronic diaries or devices, and understand questionnaires.
- Medically stable without significant recent changes in therapy or hospitalizations within 2 months.
- Agree to contraception requirements if female of childbearing potential.
- Agree not to donate blood or blood products from Day 1 until 32 weeks after dosing.
- Willing to provide identification and reliable contact during the study.
- Meet criteria for higher risk non-immunocompromised or immunocompromised groups as defined by specific health conditions.
You will not qualify if you...
- Pregnant or lactating females.
- Allergy or serious reaction history to zanamivir, monoclonal antibodies, CD388, or placebo components.
- Diagnosis of influenza within 6 months before randomization.
- Received current seasonal influenza vaccine within 14 days prior to dosing.
- Acute or febrile illness within 7 days prior to dosing.
- Close contact with lab-confirmed influenza or COVID-19 cases within 7 days prior to randomization.
- Clinically unstable conditions or psychiatric issues that may affect participation.
- History of alcohol or drug abuse affecting study conduct.
- Major surgery within 4 weeks prior to randomization or planned during study.
- Severe chronic kidney disease or receiving hemodialysis.
- Abnormal ECG findings unless stable and explained by known condition.
- Participation in another clinical study with study intervention during this study.
- Recent use of drugs or biologics for influenza prevention or treatment.
- Significant bleeding disorders or recent blood donation.
- Direct involvement or conflict of interest with the study team or sponsor.
- Any condition increasing risk, impairing participation, or affecting data interpretation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments including rapid antigen tests for influenza and COVID-19
Duration - Single treatment day with monitoring up to 24 weeks
Participants receive a single dose of CD388 or placebo by subcutaneous injection to evaluate prevention of influenza.
Visits on Day 1 (treatment), Day 8, Day 29, and Day 197 (end of study) for assessments and blood sampling
Trial Site Locations
Total: 181 locations
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Active, Not Recruiting
2
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
Active, Not Recruiting
3
HOPE Research Institute
Glendale, Arizona, United States, 85308
Active, Not Recruiting
4
Desert Clinical Research, LLC / Avacare
Mesa, Arizona, United States, 85213
Active, Not Recruiting
5
Foothills Research Center / Avacare
Phoenix, Arizona, United States, 85044
Active, Not Recruiting
6
Fiel Family and Sports Medicine / Avacare
Tempe, Arizona, United States, 85283
Active, Not Recruiting
7
HOPE Research Institute
Tempe, Arizona, United States, 85284
Active, Not Recruiting
8
Arizona Clinical Trials
Tucson, Arizona, United States, 85711
Active, Not Recruiting
9
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
Active, Not Recruiting
10
Triallogix Medical Corporation
Fullerton, California, United States, 92835
Active, Not Recruiting
11
National Institute of Clinical Research, Inc.
Garden Grove, California, United States, 92844
Active, Not Recruiting
12
Eximia Research-CA, LLC
La Mesa, California, United States, 91942
Active, Not Recruiting
13
Kinetic Clinical Research, LLC dba Long Beach Clinical Trials
Long Beach, California, United States, 90806
Active, Not Recruiting
14
Seaside Medical Group
Oceanside, California, United States, 92058
Active, Not Recruiting
15
Profound Research, LLC
Pasadena, California, United States, 91105
Active, Not Recruiting
16
Paradigm Clinical Research
Redding, California, United States, 96001
Active, Not Recruiting
17
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Active, Not Recruiting
18
Acclaim Clinical Research
San Diego, California, United States, 92120
Active, Not Recruiting
19
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Active, Not Recruiting
20
Tekton Research, LLC
Denver, Colorado, United States, 80238
Active, Not Recruiting
21
Tekton Research, LLC
Fort Collins, Colorado, United States, 80525
Active, Not Recruiting
22
Critical Care, Pulmonary and Sleep Associates PLLP / Avacare
Lakewood, Colorado, United States, 80228
Active, Not Recruiting
23
Tekton Research, LLC
Longmont, Colorado, United States, 80501
Active, Not Recruiting
24
New England Research Associates
Bridgeport, Connecticut, United States, 06606
Active, Not Recruiting
25
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Active, Not Recruiting
26
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States, 20009
Active, Not Recruiting
27
Imagine Research - Palm Beach County
Boynton Beach, Florida, United States, 33435
Active, Not Recruiting
28
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
Active, Not Recruiting
29
Hillcrest Medical Research, LLC
DeLand, Florida, United States, 32720
Active, Not Recruiting
30
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Active, Not Recruiting
31
Columbus Clinical Services, LLC
Miami, Florida, United States, 33125
Active, Not Recruiting
32
Flourish Research - Miami, LLC DBA Flourish Research
Miami, Florida, United States, 33135
Active, Not Recruiting
33
South Florida Research Center, Inc.
Miami, Florida, United States, 33135
Active, Not Recruiting
34
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Active, Not Recruiting
35
Healthcare Clinical Data, Inc.
North Miami, Florida, United States, 33161
Active, Not Recruiting
36
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
Active, Not Recruiting
37
Progressive Medical Research
Port Orange, Florida, United States, 32127
Active, Not Recruiting
38
Health Awareness, Inc.
Port Saint Lucie, Florida, United States, 34952
Active, Not Recruiting
39
Global Clinical Professionals
St. Petersburg, Florida, United States, 33705
Active, Not Recruiting
40
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States, 32789
Active, Not Recruiting
41
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Active, Not Recruiting
42
DelRicht Research
Atlanta, Georgia, United States, 30329
Active, Not Recruiting
43
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
Active, Not Recruiting
44
Paradigm Clinical Research
Boise, Idaho, United States, 83709
Active, Not Recruiting
45
Velocity Clinical Research - Boise
Meridian, Idaho, United States, 83642
Active, Not Recruiting
46
Great Lakes Clinical Trials, LLC dba Flourish Research
Chicago, Illinois, United States, 60640
Active, Not Recruiting
47
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States, 46383
Active, Not Recruiting
48
Integrated Clinical Trial Services, LLC
West Des Moines, Iowa, United States, 50265
Active, Not Recruiting
49
Johnson County Clin-Trials, LLC
Lenexa, Kansas, United States, 66219
Active, Not Recruiting
50
AMR Clinical
Newton, Kansas, United States, 67114
Active, Not Recruiting
51
DelRicht Research
Louisville, Kentucky, United States, 40205
Active, Not Recruiting
52
Elevate Clinical Research
Lake Charles, Louisiana, United States, 70605
Active, Not Recruiting
53
DelRicht Research
New Orleans, Louisiana, United States, 70115
Active, Not Recruiting
54
DelRicht Research
Prairieville, Louisiana, United States, 70769
Active, Not Recruiting
55
Annapolis Internal Medicine / Avacare
Annapolis, Maryland, United States, 21401
Active, Not Recruiting
56
Jadestone Clinical Research, LLC
Silver Spring, Maryland, United States, 20904
Active, Not Recruiting
57
Skylight Health Research
Burlington, Massachusetts, United States, 01803
Active, Not Recruiting
58
Profound Research, LLC
Clarkston, Michigan, United States, 48346
Active, Not Recruiting
59
Profound Research, LLC
Dearborn, Michigan, United States, 48126
Active, Not Recruiting
60
Profound Research, LLC
Farmington Hills, Michigan, United States, 48334
Active, Not Recruiting
61
Javara, Inc.
Mankato, Minnesota, United States, 56001
Active, Not Recruiting
62
DelRicht Research
Gulfport, Mississippi, United States, 39503
Active, Not Recruiting
63
Clay Platte Family Medicine, PC / Avacare
Kansas City, Missouri, United States, 64151
Active, Not Recruiting
64
DelRicht Research
Springfield, Missouri, United States, 65807
Active, Not Recruiting
65
Sundance Clinical Research, LLC
St Louis, Missouri, United States, 63141
Active, Not Recruiting
66
Montana Medical Research, Inc.
Missoula, Montana, United States, 59808
Active, Not Recruiting
67
Methodist Physicians Clinic / Avacare
Fremont, Nebraska, United States, 68025
Active, Not Recruiting
68
Velocity Clinical Research - Omaha
Omaha, Nebraska, United States, 68134
Active, Not Recruiting
69
Midwest Regional Health Services, LLC / Avacare
Omaha, Nebraska, United States, 68144
Active, Not Recruiting
70
Henderson Clinical Trials
Henderson, Nevada, United States, 89052
Active, Not Recruiting
71
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Active, Not Recruiting
72
Santa Rosa Medical Centers of Nevada / Avacare
Las Vegas, Nevada, United States, 89119
Active, Not Recruiting
73
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States, 89030
Active, Not Recruiting
74
IMA Clinical Research
Warren Township, New Jersey, United States, 07059
Active, Not Recruiting
75
Brooklyn Clinical Research
Brooklyn, New York, United States, 11226
Active, Not Recruiting
76
Finger Lakes Medical Research, PLLC dba Certified Research Associates
Cortland, New York, United States, 13045
Active, Not Recruiting
77
Drug Trials America
Hartsdale, New York, United States, 10530
Active, Not Recruiting
78
Rochester Clinical Research
Rochester, New York, United States, 14609
Active, Not Recruiting
79
CHEAR Center, LLC
The Bronx, New York, United States, 10455
Active, Not Recruiting
80
DelRicht Research
Charlotte, North Carolina, United States, 28205
Active, Not Recruiting
81
Eximia EquiHealth Research, LLC
Durham, North Carolina, United States, 27704
Active, Not Recruiting
82
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Active, Not Recruiting
83
West Clinical Research, Inc.
Morehead City, North Carolina, United States, 28557
Active, Not Recruiting
84
OnSite Clinical Solutions, LLC
Salisbury, North Carolina, United States, 28144
Active, Not Recruiting
85
Wilmington Health
Wilmington, North Carolina, United States, 28412
Active, Not Recruiting
86
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
87
Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States, 44122
Active, Not Recruiting
88
Velocity Clinical Research - Springdale
Cincinnati, Ohio, United States, 45246
Active, Not Recruiting
89
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States, 43213
Active, Not Recruiting
90
PriMed Clinical Research
Dayton, Ohio, United States, 45429
Active, Not Recruiting
91
Tekton Research, LLC
Edmond, Oklahoma, United States, 73013
Active, Not Recruiting
92
Lynn Health Science Institute East
Oklahoma City, Oklahoma, United States, 73111
Active, Not Recruiting
93
DelRicht Research
Tulsa, Oklahoma, United States, 74133
Active, Not Recruiting
94
Tekton Research, LLC
Yukon, Oklahoma, United States, 73099
Active, Not Recruiting
95
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Active, Not Recruiting
96
Central Erie Primary Care
Erie, Pennsylvania, United States, 16508
Active, Not Recruiting
97
Hatboro Medical Associates / Avacare
Horsham, Pennsylvania, United States, 19044
Active, Not Recruiting
98
DM Clinical Research
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
99
DelRicht Research
Charleston, South Carolina, United States, 29407
Active, Not Recruiting
100
Tribe Clinical Research, LLC
Greenville, South Carolina, United States, 29607
Active, Not Recruiting
101
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Active, Not Recruiting
102
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, United States, 29303
Active, Not Recruiting
103
DelRicht Research
Hendersonville, Tennessee, United States, 37075
Active, Not Recruiting
104
DCT-HCWC, LLC dba Discovery Clinical Trials
Dallas, Texas, United States, 75230
Active, Not Recruiting
105
Zenos Clinical Research
Dallas, Texas, United States, 75230
Active, Not Recruiting
106
Lonestar Clinical Research, LLC
Dallas, Texas, United States, 75243
Active, Not Recruiting
107
Laguna Clinical Research Associates, LLC
Laredo, Texas, United States, 78041
Active, Not Recruiting
108
Epic Clinical Research
Lewisville, Texas, United States, 75057
Active, Not Recruiting
109
Elevate Clinical Research
McAllen, Texas, United States, 78504
Active, Not Recruiting
110
Pearland Physicians
Pearland, Texas, United States, 77581
Active, Not Recruiting
111
Research Your Health
Plano, Texas, United States, 75093
Active, Not Recruiting
112
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, United States, 78229
Active, Not Recruiting
113
Elevate Clinical Research
Seabrook, Texas, United States, 77586
Active, Not Recruiting
114
Javara, Inc.
Stephenville, Texas, United States, 76401
Active, Not Recruiting
115
DM Clinical Research
Tomball, Texas, United States, 77375
Active, Not Recruiting
116
Cope Family Medicine / Avacare
Bountiful, Utah, United States, 84010
Active, Not Recruiting
117
Olympus Family Medicine / Avacare
Salt Lake City, Utah, United States, 84117
Active, Not Recruiting
118
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Active, Not Recruiting
119
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Active, Not Recruiting
120
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Active, Not Recruiting
121
CEMER Centro Médico Enfermedades Respiratorias
Buenos Aires, Argentina, B1602DQD
Actively Recruiting
122
Centro de Estudios Infectológicos
Buenos Aires, Argentina, C1002ABJ
Actively Recruiting
123
CINME - Centro de Investigaciones Metabolicas
Buenos Aires, Argentina, C1027AAP
Actively Recruiting
124
Equipo Ciencia
Buenos Aires, Argentina, C1428BNF
Actively Recruiting
125
Sanatorio Mayo Privado S.A.
Córdoba, Argentina, X5000FAL
Actively Recruiting
126
Instituto IBAMEDICA
Santa Fe, Argentina, S3000ASF
Actively Recruiting
127
Emeritus Research Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
128
Australian Clinical Research Network Pty Ltd
Maroubra, New South Wales, Australia, 2035
Actively Recruiting
129
AIM Research
Merewether, New South Wales, Australia, 2291
Actively Recruiting
130
Momentum Clinical Research St Leonards
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
131
Core Research Group Pty Ltd
Milton, Queensland, Australia, 4064
Actively Recruiting
132
Momentum Clinical Research Taringa
Taringa, Queensland, Australia, 4062
Actively Recruiting
133
Emeritus Research Camberwell
Camberwell, Victoria, Australia, 3124
Actively Recruiting
134
Josha Research
Bloemfontein, Free State, South Africa, 9300
Actively Recruiting
135
University of Witwatersrand, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Actively Recruiting
136
Ubuntu Clinical Research
Lenasia, Gauteng, South Africa, 1827
Actively Recruiting
137
Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, South Africa, 3370
Actively Recruiting
138
Madibeng Centre for Research
Brits, North West, South Africa, 0250
Actively Recruiting
139
Tiervlei Trial Centre
Bellville, South Africa, 7530
Actively Recruiting
140
TREAD Research (Pty) Ltd
Bellville, South Africa, 7530
Actively Recruiting
141
TASK Applied Science, Central
Cape Town, South Africa, 7530
Actively Recruiting
142
Paarl Research Centre
Cape Town, South Africa, 7646
Actively Recruiting
143
CAPRISA eThekwini Clinical Research Site
Durban, South Africa, 4001
Actively Recruiting
144
Synergy Biomed Research Institute
East London, South Africa, 5201
Actively Recruiting
145
Newtown Clinical Research Centre
Johannesburg, South Africa, 2001
Actively Recruiting
146
Isango Lethemba TB Research Unit
Port Elizabeth, South Africa, 6003
Actively Recruiting
147
Emmed Research
Pretoria, South Africa, 0002
Actively Recruiting
148
Global Clinical Trials (Pty) Ltd
Pretoria, South Africa, 0157
Actively Recruiting
149
Jongaie Research
Pretoria, South Africa, 0183
Actively Recruiting
150
The Aurum Institute
Rustenburg, South Africa, 0299
Actively Recruiting
151
Welkom Clinical Trial Centre
Welkom, South Africa, 9460
Actively Recruiting
152
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom, B15 2TH
Active, Not Recruiting
153
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, England, United Kingdom, FY3 7EN
Active, Not Recruiting
154
Southmead Hospital, North Bristol NHS Trust - Clinical Research Centre
Bristol, England, United Kingdom, BS10 5NB
Active, Not Recruiting
155
Velocity Clinical Research - Bristol
Bristol, England, United Kingdom, BS8 2RA
Active, Not Recruiting
156
Eynsham Medical Centre
Eynsham, England, United Kingdom, OX29 4QB
Active, Not Recruiting
157
Velocity Clinical Research - High Wycombe
High Wycombe, England, United Kingdom, HP11 2QW
Active, Not Recruiting
158
HMC Health, The Meadows Centre for Health, The Great West Surgery
Hounslow, England, United Kingdom, TW4 7NR
Active, Not Recruiting
159
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Active, Not Recruiting
160
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Active, Not Recruiting
161
hVIVO Services Limited
London, England, United Kingdom, E1 1EQ
Active, Not Recruiting
162
Panthera Enfield
London, England, United Kingdom, EN3 4GS
Active, Not Recruiting
163
Velocity Clinical Research - North London
London, England, United Kingdom, N12 8BU
Active, Not Recruiting
164
North Manchester General Hospital
Manchester, England, United Kingdom, M8 5RB
Active, Not Recruiting
165
The University of Nottingham Health Service
Nottingham, England, United Kingdom, NG7 2QW
Active, Not Recruiting
166
Wansford Research LTD
Peterborough, England, United Kingdom, PE8 6PL
Active, Not Recruiting
167
University Hospitals Plymouth NHS Trust
Plymouth, England, United Kingdom, PL6 8DH
Active, Not Recruiting
168
Panthera Preston
Preston, England, United Kingdom, PR2 9QB
Active, Not Recruiting
169
Panthera Rochdale
Rochdale, England, United Kingdom, OL11 4AU
Active, Not Recruiting
170
Velocity Clinical Research - Romford
Romford, England, United Kingdom, RM1 3PJ
Active, Not Recruiting
171
Warrington and Halton Teaching Hospitals NHS Foundation Trust
Runcorn, England, United Kingdom, WA7 2DA
Active, Not Recruiting
172
Salford Royal Hospital
Salford, England, United Kingdom, M6 8HD
Active, Not Recruiting
173
Panthera Sheffield
Sheffield, England, United Kingdom, S2 5FX
Active, Not Recruiting
174
University Hospital Southampton NHS Foundation Trust, NIHR Southampton Clinical Research Facility
Southampton, England, United Kingdom, SO16 6YD
Active, Not Recruiting
175
Royal Cornwall Hospitals NHS Trust
Truro, England, United Kingdom, TR1 3LJ
Active, Not Recruiting
176
Windrush Medical Practice
Witney, England, United Kingdom, OX28 6JS
Active, Not Recruiting
177
Panthera York
York, England, United Kingdom, YO24 4LJ
Active, Not Recruiting
178
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZD
Active, Not Recruiting
179
NHS Lothian - Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Active, Not Recruiting
180
Queen Elizabeth University Hospital, Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom, G51 4TF
Active, Not Recruiting
181
Cardiff and Vale UHB - University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Active, Not Recruiting
Research Team
H
Head of Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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