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ClinicalTrials.gov

Trial records, trial locations and study sponsors

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ClinicalTrials.gov helps users find studies and view public trial records, including sponsor-run or funded studies; site distances are approximate, and contacts, eligibility, or exact dates may be missing.

Get trial

Get the full public record for a clinical trial by NCT number or title. For ambiguous titles, returns the closest matching registered title. Dates without a recorded day are returned as null.

Your information

The trial title or NCT trial number, for example NCT04368728.

1 credit per completed run

The same inputs also work from your code or an AI assistant. See For developers.

Example results

Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine

This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. A total of 300 adult individuals received a single dose of either the SpikoGen vaccine or the saline placebo in a 5:1 ratio at 4 to 9 months after the second dose of a COVID-19 vaccine of any type. The injection was given in the deltoid muscle of the non-dominant arm. On day 14, the trial was unblinded, and the participants in the placebo group received a booster dose of the SpikoGen vaccine. For immunogenicity assessments, blood samples were collected on days 0 and 14 from all participants and on days 90 and 180 from those in the vaccine group only. For safety assessments, all participants were followed up for six months. Study hypotheses included: 1. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects. 2. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.

Participants300
PhasePhase 3
Completed
Sponsor
Cinnagen
Age range
18 Years and older
Started
Dec 15, 2021
Completion date
Jun 20, 2022
Official title
A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen)

Study arms

  • SpikoGen COVID-19 Vaccine

    Experimental

    • Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

  • Saline Placebo

    Placebo Comparator

    • Biological: Saline placebo

Treatments

  • SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

    Biological

    SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm

    Used in these arms

    • SpikoGen COVID-19 Vaccine

  • Saline placebo

    Biological

    0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm

    Used in these arms

    • Saline Placebo

Primary outcomes

  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

    14 days after the booster dose

    As measured by ELISA

Secondary outcomes

  • Incidence of solicited adverse events

    For 7 days after the booster dose

    Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

  • Incidence of unsolicited adverse events

    For 14 days after the booster dose

    As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

  • Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)

    For 6 months after the booster dose

    As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

  • Geometric mean concentration (GMC) for S1 binding IgG antibodies

    Days 0, 14, 90, and 180

    As measured by ELISA

  • Geometric mean fold rise (GMFR) for S1 binding IgG antibodies

    14 days after the booster dose

    As measured by ELISA

  • Percentage of participants with seroconversion for S1 binding IgG antibodies

    14 days after the booster dose

    As measured by ELISA

  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies

    14 days after the booster dose

    As measured by ELISA

  • Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies

    Days 0, 14, 90, and 180

    As measured by ELISA

  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies

    14 days after the booster dose

    As measured by ELISA

  • Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies

    Days 0, 14, 90, and 180

    As measured by ELISA

  • Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies

    14 days after the booster dose

    As measured by ELISA

  • Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose

    Days 0 and 14

    As measured by IGRA

Eligibility

Inclusion Criteria: * Male or female ≥18 years * Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests * Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit * Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit Exclusion Criteria: * Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit * Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine * Subjects with epilepsy or a history of febrile seizures * Subjects who receive immunosuppressive or cytotoxic medications. * Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. * Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. * Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study. * Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection. * Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study injection. * Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period. * Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion. * Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.

Locations

  • Orchid Life Department, Orchid Pharmed Company

    Tehran, Iran

Public contacts

Choose an action

About the ClinicalTrials.gov tool

Search trials finds studies by condition or medicine, with optional location, distance, recruitment status, and phase filters.

Get trial returns a public study record using an NCT number or title, including treatments, arms, locations, and public contacts.

List company trials returns studies for a sponsor, with optional phase, status, and condition filters.

Built from clinicaltrials.gov and nominatim.openstreetmap.org. Last checked Sep 29, 2026.

Actions

Get trial

1 credit

Get the full public record for a clinical trial by NCT number or title. For ambiguous titles, returns the closest matching registered title. Dates without a recorded day are returned as null.

What you provide

FieldTypeRequiredDescription
TrialtrialTextRequiredThe trial title or NCT trial number, for example NCT04368728.Example: NCT05175625

What you get

FieldTypeDescription
ArmsarmsList
Namearms[].nameTextExample: SpikoGen COVID-19 Vaccine
Typearms[].typeTextExample: Experimental
Treatmentsarms[].treatmentsList
Descriptionarms[].descriptionText
PhasephaseTextExample: Phase 3
TitletitleTextExample: Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine
StatusstatusTextExample: Completed
SponsorsponsorTextExample: Cinnagen
Age Rangeage_rangeTextExample: 18 Years and older
LocationslocationsList
Citylocations[].cityTextExample: Tehran
Countrylocations[].countryTextExample: Iran
Facilitylocations[].facilityTextExample: Orchid Life Department, Orchid Pharmed Company
Recruitment Statuslocations[].recruitment_statusText
Start Datestart_dateDateExample: 2021-12-15
TreatmentstreatmentsList
Armstreatments[].armsList
Nametreatments[].nameTextExample: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Typetreatments[].typeTextExample: Biological
Descriptiontreatments[].descriptionTextExample: SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a…
Trial Linktrial_linkTextExample: https://clinicaltrials.gov/study/NCT05175625
Trial Numbertrial_numberTextExample: NCT05175625
Official Titleofficial_titleTextExample: A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group…
Results Postedresults_postedYes or noExample: No
Completion Datecompletion_dateDateExample: 2022-06-20
Public Contactspublic_contactsList
Namepublic_contacts[].nameText
Rolepublic_contacts[].roleText
Emailpublic_contacts[].emailText
Phonepublic_contacts[].phoneText
Facilitypublic_contacts[].facilityText
Purpose Summarypurpose_summaryText
Primary Outcomesprimary_outcomesList
Measureprimary_outcomes[].measureTextExample: Percentage of participants with seroconversion for SARS-CoV-2 neutralizing…
Time Frameprimary_outcomes[].time_frameTextExample: 14 days after the booster dose
Descriptionprimary_outcomes[].descriptionTextExample: As measured by ELISA
Secondary Outcomessecondary_outcomesList
Measuresecondary_outcomes[].measureTextExample: Incidence of solicited adverse events
Time Framesecondary_outcomes[].time_frameTextExample: For 7 days after the booster dose
Descriptionsecondary_outcomes[].descriptionTextExample: Injection site pain, erythema, swelling, and induration, axillary swelling or…
Eligibility Criteriaeligibility_criteriaText
Number of Participantsnumber_of_participantsNumberExample: 300

Example result

For Trial: NCT05175625

JSON
{
  "arms": [
    {
      "name": "SpikoGen COVID-19 Vaccine",
      "type": "Experimental",
      "treatments": [
        "Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant"
      ],
      "description": null
    }
  ],
  "phase": "Phase 3",
  "title": "Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine",
  "status": "Completed",
  "sponsor": "Cinnagen",
  "age_range": "18 Years and older",
  "locations": [
    {
      "city": "Tehran",
      "country": "Iran",
      "facility": "Orchid Life Department, Orchid Pharmed Company",
      "recruitment_status": null
    }
  ],
  "start_date": "2021-12-15",
  "treatments": [
    {
      "arms": [
        "SpikoGen COVID-19 Vaccine"
      ],
      "name": "SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant",
      "type": "Biological",
      "description": "SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm"
    }
  ],
  "trial_link": "https://clinicaltrials.gov/study/NCT05175625",
  "trial_number": "NCT05175625",
  "official_title": "A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19…",
  "results_posted": false,
  "completion_date": "2022-06-20",
  "public_contacts": [],
  "purpose_summary": "This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subu…",
  "primary_outcomes": [
    {
      "measure": "Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies",
      "time_frame": "14 days after the booster dose",
      "description": "As measured by ELISA"
    }
  ],
  "secondary_outcomes": [
    {
      "measure": "Incidence of solicited adverse events
…

List company trials

1 credit

List studies run or funded by a sponsor, newest start date first. Dates without a full day are returned as null.

What you provide

FieldTypeRequiredDescription
PhasephaseTextOptionalStudy phase to include, such as phase_3; any includes all phases.Example: Phase 3
StatusstatusTextOptionalStudy recruitment status, such as recruiting; any includes all statuses.Example: Recruiting
SponsorsponsorTextRequiredCompany or organization sponsoring or collaborating on studies, such as Pfizer.Example: Pfizer
ConditionconditionTextOptionalCondition to match, such as obesity.Example: Obesity
Max Resultsmax_resultsNumberOptionalMaximum number of studies to return, such as 50 (up to 200).Example: 10

What you get

FieldTypeDescription
TrialstrialsListMatching trials sorted by start date, newest first.
Phasetrials[].phaseTextStudy phase or phases in words.Example: Phase 3
Statustrials[].statusTextOverall study status in words.Example: Recruiting
Conditionstrials[].conditionsListConditions studied.
Start Datetrials[].start_dateTextStart date as YYYY-MM-DD when the day is known.Example: 2026-06-10
Trial Linktrials[].trial_linkTextClinicalTrials.gov study page.Example: https://clinicaltrials.gov/study/NCT07595549
Trial Titletrials[].trial_titleTextPublic study title.Example: A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in…
Trial Numbertrials[].trial_numberTextNCT study number.Example: NCT07595549
Number of Participantstrials[].number_of_participantsNumberEnrolled or planned number of participants.Example: 954
Primary Completion Datetrials[].primary_completion_dateTextPrimary completion date as YYYY-MM-DD when the day is known.Example: 2028-05-04

Example result

For Phase: Phase 3, Status: Recruiting, Sponsor: Pfizer, Condition: Obesity, Max Results: 10

JSON
{
  "trials": [
    {
      "phase": "Phase 3",
      "status": "Recruiting",
      "conditions": [
        "Obesity",
        "Overweight and/or Obesity",
        "Overweight"
      ],
      "start_date": "2026-06-10",
      "trial_link": "https://clinicaltrials.gov/study/NCT07595549",
      "trial_title": "A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity",
      "trial_number": "NCT07595549",
      "number_of_participants": 954,
      "primary_completion_date": "2028-05-04"
    }
  ]
}

Search trials

1 credit

Find ClinicalTrials.gov studies for a condition or medicine, with optional location, distance, recruitment status, and phase filters. With a location, results are ordered by distance to their closest eligible registered site. Site distances are approximate straight-line miles; contact and eligibility information may be missing.

Uses ClinicalTrials.gov and nominatim.openstreetmap.org.

What you provide

FieldTypeRequiredDescription
PhasephaseTextOptionalStudy phase, for example phase_3 or any.Example: Phase 3
LocationlocationTextOptionalCity, state, or country for nearby trials, for example Boston, MA.Example: Boston, MA
ConditionconditionTextRequiredCondition or medicine to search, for example breast cancer or semaglutide.Example: Semaglutide
Max Resultsmax_resultsNumberOptionalMaximum number of trials to return, for example 20 (up to 100).Example: 3
Distance (miles)distance_milesNumberOptionalSearch radius in miles when a location is given, for example 50.Example: 50
Recruiting Onlyrecruiting_onlyYes or noOptionalInclude only studies recruiting or preparing to recruit, for example true.Example: Yes

What you get

FieldTypeDescription
TrialstrialsList
Sextrials[].sexTextExample: All
Phasetrials[].phaseTextExample: Not applicable
Statustrials[].statusTextExample: Recruiting
Sponsortrials[].sponsorTextExample: University College Dublin
Age Rangetrials[].age_rangeTextExample: 18 Years and older
Conditionstrials[].conditionsList
Start Datetrials[].start_dateTextExample: 2022-06-22
Trial Linktrials[].trial_linkTextExample: https://clinicaltrials.gov/study/NCT04174755
Trial Titletrials[].trial_titleTextExample: Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Contact Nametrials[].contact_nameTextExample: Aoife Cotter, PhD
Trial Numbertrials[].trial_numberTextExample: NCT04174755
Contact Emailtrials[].contact_emailTextExample: [email protected]
Contact Phonetrials[].contact_phoneTextExample: 562-826-8000
Distance (miles)trials[].distance_milesNumberExample: 0.1
Nearest Site Citytrials[].nearest_site_cityTextExample: Dublin
Healthy Volunteerstrials[].healthy_volunteersYes or noExample: No
Nearest Site Statetrials[].nearest_site_stateTextExample: Dublin
Nearest Site Countrytrials[].nearest_site_countryTextExample: Ireland
Nearest Site Facilitytrials[].nearest_site_facilityTextExample: Mater Misericordiae University Hospital

Example result

For Condition: Semaglutide, Max Results: 3

JSON
{
  "trials": [
    {
      "sex": "All",
      "phase": "Not applicable",
      "status": "Recruiting",
      "sponsor": "University College Dublin",
      "age_range": "18 Years and older",
      "conditions": [
        "Obesity",
        "HIV-1-infection"
      ],
      "start_date": "2022-06-22",
      "trial_link": "https://clinicaltrials.gov/study/NCT04174755",
      "trial_title": "Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV",
      "contact_name": "Aoife Cotter, PhD",
      "trial_number": "NCT04174755",
      "contact_email": "[email protected]",
      "contact_phone": null,
      "distance_miles": null,
      "nearest_site_city": "Dublin",
      "healthy_volunteers": false,
      "nearest_site_state": "Dublin",
      "nearest_site_country": "Ireland",
      "nearest_site_facility": "Mater Misericordiae University Hospital"
    },
    {
      "sex": "All",
      "phase": "Phase 3",
      "status": "Recruiting",
      "sponsor": "VA Office of Research and Development",
      "age_range": "18 Years to 80 Years",
      "conditions": [
        "Alcohol Use Disorder"
      ],
      "start_date": "2026-07-28",
      "trial_link": "https://clinicaltrials.gov/study/NCT07218354",
      "trial_title": "Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)",
      "contact_name": "Larry Albers, MD",
      "trial_number": "NCT07218354",
      "contact_email": "[email protected]",
      "contact_phone": "562-826-8000",
      "distance_miles": null,
      "nearest_site_city": "Long Beach",
      "healthy_volunteers": true,
      "nearest_site_state": "California",
      "nearest_site_country": "United States",
      "nearest_site_facility": "VA Long Beach Healthcare System, Long Beach, CA"
    }
  ]
}

For developers

Call it from your code with one request. Change the values in input to run it on new data. To get an API key, open Developers at the bottom of Studio, turn on Developer mode and go to API keys.

cURL
curl 'https://api.fous.com/v1/query' \
  --fail-with-body --silent --show-error --max-time 180 \
  -H "Authorization: Bearer YOUR_API_KEY" \
  -H 'Content-Type: application/json' \
  --data-raw '{
  "api": "@clinicaltrials-gov",
  "visibility": "public",
  "operation": "get_trial",
  "version": 1,
  "input": {
    "trial": "NCT05175625"
  },
  "response": {
    "format": "json"
  }
}'

What you can do with it

  • Find recruiting trials for a condition near a city
  • Review a trial’s treatments, arms, locations, and public contacts
  • Compare company studies by phase, status, or condition
  • Track study start dates and participant counts by sponsor

Questions about ClinicalTrials.gov

Can I run it with my own inputs?

Yes. Change the inputs in Studio and press Run, or send new inputs from your code, or ask a connected AI assistant.

Can I call this ClinicalTrials.gov tool as an API?

Yes. Send a POST request to /v1/query with your Fous API key and the inputs, and get JSON back.

How much does it cost?

Each completed run costs 1 credit. Failed runs without a completed receipt are free; completed work can remain charged if delivery is interrupted. With pay as you go, a credit costs 1¢. Monthly plans cost less per credit.

Do I need a ClinicalTrials.gov account?

No. You only need a Fous account.

How current is the data?

Fous gets the data from clinicaltrials.gov when you run it. Some results are reused for up to 24 hours, and results that use your account or key are never reused. It was last verified on Sep 29, 2026.

Which trials are recruiting near a location?

Search trials finds studies for a condition or medicine and can filter by location, distance, recruitment status, and phase.

What treatments and locations are listed for a trial?

Get trial returns a public record with treatments, study arms, locations, and recruitment status by location.

What studies is a company sponsoring?

List company trials returns studies for a sponsor, with optional filters for phase, status, and condition.

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